Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome.
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT01589237
Collaborator
(none)
38
10
1
28.9
3.8
0.1
Study Details
Study Description
Brief Summary
This study was to determine long-term safety and tolerability, and continued efficacy in lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS) (HLP type I).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This study was an 52 weeks open label extension starting at the lowest treatment dose used in CLCQ908B2302/NCT01514461 (i.e., 10 mg) with optional up-titrations, to evaluate the overall long-term safety and tolerability of LCQ908 in patients with Familial Chylomicronemia Syndrome, who either discontinued from the CLCQ908B2302/NCT01514461 study (due to tolerability issues) or completed the CLCQ908B2302/NCT01514461 study after 52 weeks. In addition, patients who had previously completed study CLCQ908A2212/NCT01146522 were eligible to participate.
Following Protocol amendment 2, the original 52 week duration of this study (CLCQ908B2305) became Part A of LCQ908B2305 and a 78 week extension became Part B. However, following Protocol amendment 3, Part B was ended at the same time as the last patient of Part A completed 52 weeks. The reason for termination of Part B was the findings from the December 2014 interim analysis which suggested that the size of benefit that was anticipated from continued participation of patients in the 18 month extension trial (Part B) no longer supported trial extension beyond Part A.
Study Design
Study Type:
Interventional
Actual Enrollment
:
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, 52-week, Safety and Tolerability Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome.
Study Start Date
:
Feb 1, 2013
Actual Primary Completion Date
:
Jul 1, 2015
Actual Study Completion Date
:
Jul 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LCQ908 Patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose will be allowed. One down titration allowed from the highest dose attained. |
Drug: LCQ908
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With Any Adverse Events, Serious Adverse Events and Death [52 weeks]
Secondary Outcome Measures
- Changes From Baseline in Triglyceride Levels up to 52 Weeks [Baseline, Week 12, 24 and 52]
Blood samples were collected for a fasting lipid panel, including total triglycerides. Lipid measurements were collected after a 12 hour (overnight) fast. The maintenance of effect was assessed on triglyceride levels during continued therapy with LCQ908 for up to 52 weeks. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.
- Changes From Baseline in Cholesterol Levels up to 52 Weeks [Baseline, Week 12, 24 and 52]
Blood samples were collected for a fasting lipid panel, including cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.
- Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks [Baseline, Week 12, 24 and 52]
Blood samples were collected for a fasting lipid panel, including HDL and non HDL cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.
- Changes From Baseline in Glycerol Levels up to 52 Weeks [Baseline, Week 12, 24 and 52]
Blood samples were collected for a fasting lipid panel, including glycerol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.
- Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks [Baseline, Week 12, 24 and 52]
Blood samples were collected for a fasting lipid panel, including free fatty acid level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.
- Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks [Baseline, Week 12, 24 and 52]
Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein A1. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.
- Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks [Baseline, Week 12, 24 and 52]
Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-48. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.
- Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks [Baseline, Week 12, 24 and 52]
Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-100. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Written informed consent must be obtained before any assessment is performed.
-
Subjects that either discontinue prematurely or complete the CLCQ908B2302 study after 52 weeks or FCS subjects who have previously completed study CLCQ908A2212.
Exclusion Criteria:
-
Subjects discontinued from the CLCQ908B2302 study for serious, potentially study drug related adverse events.
-
Subjects from the CLCQ908B2302 study who have developed any other contraindication to participation (for example, renal failure)
-
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
-
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
-
Subjects with type 1 diabetes mellitus or type 2 diabetes mellitus if HbA1C is ≥ 8.5%.
-
Treatment with fish oil preparations within 4 weeks prior to randomization.
-
Treatment with bile acid binding resins (i.e., colesevelam, etc) within 4 weeks prior to randomization.
-
Treatment with fibrates within 8 weeks prior to randomization. Washout may occur following screening if required.
-
Glybera [alipogene tiparvovec (AAV1-LPLS447X )] gene therapy exposure within the two years prior to screening.
-
eGFR <45 ml/min/1.73m2 or history of chronic renal disease.
Other protocol defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Seatlle | Washington | United States | 98104 |
| 2 | Novartis Investigative Site | Chicoutimi | Quebec | Canada | G7H 7P2 |
| 3 | Novartis Investigative Site | Ste-Foy | Quebec | Canada | G1V4M6 |
| 4 | Novartis Investigative Site | Ouest-Montreal | Canada | H2W1R7 | |
| 5 | Novartis Investigative Site | Nantes | France | 44093 | |
| 6 | Novartis Investigative Site | Paris Cedex 13 | France | 75651 | |
| 7 | Novartis Investigative Site | Hamburg | Germany | 20246 | |
| 8 | Novartis Investigative Site | Meibergdreef 9 | Netherlands | 1105 AZ | |
| 9 | Novartis Investigative Site | Cape Town | South Africa | 7925 | |
| 10 | Novartis Investigative Site | Manchester | United Kingdom | M13 9NT |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01589237
Other Study ID Numbers:
- CLCQ908B2305
- 2012-000802-32
First Posted:
May 1, 2012
Last Update Posted:
Nov 15, 2016
Last Verified:
Sep 1, 2016
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 100% patients who completed the screening phase were enrolled in the study. |
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 |
|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. |
| Period Title: Part A (52 Weeks) | ||||
| STARTED | 11 | 12 | 10 | 5 |
| COMPLETED | 9 | 9 | 8 | 5 |
| NOT COMPLETED | 2 | 3 | 2 | 0 |
| Period Title: Part A (52 Weeks) | ||||
| STARTED | 5 | 6 | 4 | 4 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 5 | 6 | 4 | 4 |
Baseline Characteristics
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | Total of all reporting groups |
| Overall Participants | 11 | 12 | 10 | 5 | 38 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
52.9
(10.22)
|
44.1
(14.26)
|
43.6
(84.53)
|
52.2
(12.72)
|
47.6
(11.43)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
5
45.5%
|
6
50%
|
2
20%
|
3
60%
|
16
42.1%
|
| Male |
6
54.5%
|
6
50%
|
8
80%
|
2
40%
|
22
57.9%
|
Outcome Measures
| Title | Number of Patients With Any Adverse Events, Serious Adverse Events and Death |
|---|---|
| Description | |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety set (SAF) - All subjects who received at least one dose of study drug and had at least one post-baseline safety assessment in this extension study. |
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 |
|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. |
| Measure Participants | 11 | 12 | 10 | 5 |
| At least one Adverse Event (any) |
11
100%
|
12
100%
|
10
100%
|
5
100%
|
| At least one serious AE |
1
9.1%
|
6
50%
|
2
20%
|
2
40%
|
| Death |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Changes From Baseline in Triglyceride Levels up to 52 Weeks |
|---|---|
| Description | Blood samples were collected for a fasting lipid panel, including total triglycerides. Lipid measurements were collected after a 12 hour (overnight) fast. The maintenance of effect was assessed on triglyceride levels during continued therapy with LCQ908 for up to 52 weeks. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100. |
| Time Frame | Baseline, Week 12, 24 and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. |
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 |
|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. |
| Measure Participants | 11 | 12 | 10 | 5 |
| Change in week 12 (n=10,11,10,5) |
1.63
(45.19)
|
-5.80
(66.10)
|
43.94
(52.66)
|
-19.36
(42.82)
|
| change in week 24 (n=10,10,9,5) |
-14.59
(52.33)
|
-36.19
(64.80)
|
32.54
(87.83)
|
-26.05
(31.50)
|
| change in week 52 (n=9,8,9,5) |
16.46
(29.27)
|
-30.03
(78.52)
|
92.15
(60.21)
|
-9.20
(43.34)
|
| Title | Changes From Baseline in Cholesterol Levels up to 52 Weeks |
|---|---|
| Description | Blood samples were collected for a fasting lipid panel, including cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100. |
| Time Frame | Baseline, Week 12, 24 and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. |
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 |
|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. |
| Measure Participants | 11 | 12 | 10 | 5 |
| Change in week 12 (n=10,11,10,5) |
-5.58
(36.38)
|
-4.76
(36.26)
|
18.76
(31.54)
|
-10.42
(24.68)
|
| change in week 24 (n=10,10,9,5) |
-10.54
(27.87)
|
-21.54
(24.98)
|
7.45
(37.28)
|
-13.87
(25.64)
|
| change in week 52 (n=9,8,9,5) |
5.75
(17.51)
|
-13.76
(36.10)
|
40.95
(34.10)
|
-6.84
(22.55)
|
| Title | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks |
|---|---|
| Description | Blood samples were collected for a fasting lipid panel, including HDL and non HDL cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100. |
| Time Frame | Baseline, Week 12, 24 and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. |
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 |
|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. |
| Measure Participants | 11 | 12 | 10 | 5 |
| HDL: Change in week 12 (n=10,11,10,5) |
-14.13
(30.08)
|
3.37
(24.75)
|
-5.99
(22.19)
|
-7.09
(27.11)
|
| Non HDL: change in week 12 (n=10,11,10,5) |
-5.37
(39.61)
|
-7.72
(42.40)
|
20.70
(34.18)
|
-10.57
(26.16)
|
| HDL: change in week 24 (n=10,10,9,5) |
-7.11
(19.41)
|
-1.83
(31.36)
|
6.67
(22.19)
|
-15.60
(37.69)
|
| Non HDL: change in week 24 (n=10,10,9,5) |
-11.29
(29.53)
|
-25.22
(31.49)
|
7.17
(40.50)
|
-14.01
(28.04)
|
| HDL: change in week 52 (n=9,8,9,5) |
-10.85
(19.78)
|
8.11
(29.35)
|
-7.33
(27.63)
|
-21.41
(22.91)
|
| Non HDL: change in week 52 (n=9,8,9,5) |
8.06
(21.42)
|
-17.68
(42.65)
|
45.25
(37.45)
|
-6.09
(24.59)
|
| Title | Changes From Baseline in Glycerol Levels up to 52 Weeks |
|---|---|
| Description | Blood samples were collected for a fasting lipid panel, including glycerol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100. |
| Time Frame | Baseline, Week 12, 24 and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. |
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 |
|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. |
| Measure Participants | 11 | 12 | 10 | 5 |
| Change in week 12 (n=10,11,10,5) |
-26.56
(72.88)
|
-15.50
(73.33)
|
0.68
(75.40)
|
-46.83
(105.58)
|
| change in week 24 (n=10,10,9,5) |
-40.00
(67.28)
|
-46.97
(62.46)
|
-36.26
(133.58)
|
-56.99
(96.06)
|
| change in week 52 (n=9,8,9,5) |
-38.15
(70.10)
|
-31.96
(64.76)
|
-28.52
(101.85)
|
-37.02
(81.67)
|
| Title | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks |
|---|---|
| Description | Blood samples were collected for a fasting lipid panel, including free fatty acid level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100. |
| Time Frame | Baseline, Week 12, 24 and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. |
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 |
|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. |
| Measure Participants | 11 | 12 | 10 | 5 |
| Change in week 12 (n=10,11,10,5) |
-23.11
(53.05)
|
-17.85
(62.48)
|
53.09
(44.83)
|
-46.58
(128.38)
|
| change in week 24 (n=10,10,9,5) |
-20.35
(80.16)
|
-30.44
(62.01)
|
36.18
(64.97)
|
-42.74
(108.73)
|
| change in week 52 (n=9,8,9,5) |
-16.99
(43.34)
|
-7.69
(54.21)
|
79.15
(49.37)
|
-18.29
(104.77)
|
| Title | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks |
|---|---|
| Description | Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein A1. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100. |
| Time Frame | Baseline, Week 12, 24 and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. |
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 |
|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. |
| Measure Participants | 11 | 12 | 10 | 5 |
| Change in week 12 (n=11,11,10,5) |
-3.24
(23.82)
|
2.55
(15.09)
|
6.58
(17.04)
|
2.95
(33.54)
|
| change in week 24 (n=10,10,10,5) |
4.80
(14.16)
|
1.41
(17.45)
|
5.57
(25.69)
|
5.11
(28.49)
|
| change in week 52 (n=10,8,9,5) |
4.51
(19.21)
|
10.01
(16.28)
|
4.43
(19.34)
|
-0.82
(16.79)
|
| Title | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks |
|---|---|
| Description | Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-48. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100. |
| Time Frame | Baseline, Week 12, 24 and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. |
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 |
|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. |
| Measure Participants | 11 | 12 | 10 | 5 |
| Change in week 12 (n=11,11,10,5) |
-4.03
(79.87)
|
33.24
(79.20)
|
109.67
(52.50)
|
-30.03
(61.78)
|
| change in week 24 (n=10,10,10,5) |
9.13
(30.79)
|
-10.23
(58.91)
|
105.52
(71.45)
|
-35.04
(31.11)
|
| change in week 52 (n=10,8,9,5) |
56.25
(57.65)
|
-22.63
(107.21)
|
135.33
(71.11)
|
27.75
(57.77)
|
| Title | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks |
|---|---|
| Description | Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-100. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100. |
| Time Frame | Baseline, Week 12, 24 and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. |
| Arm/Group Title | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 |
|---|---|---|---|---|
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. |
| Measure Participants | 11 | 12 | 10 | 5 |
| Change in week 12 (n=9,11,9,5) |
-15.75
(41.50)
|
15.10
(58.53)
|
-8.34
(32.73)
|
3.33
(32.46)
|
| change in week 24 (n=10,9,10,5) |
-2.75
(63.10)
|
21.33
(38.76)
|
-18.28
(52.94)
|
11.68
(43.73)
|
| change in week 52 (n=10,7,9,5) |
-12.52
(44.16)
|
25.39
(36.77)
|
-10.73
(37.20)
|
10.02
(39.08)
|
Adverse Events
| Time Frame | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | Part A-placebo of Pradigastat (LCQ908) Regimen | Part A-20mg Pradigastat (LCQ908) Regimen | Part A-40mg Pradigastat (LCQ908) Regimen | Part A: Pradigastat (LCQ908) Regimen- From Study A2212 | Part B-placebo of Pradigastat (LCQ908) Regimen | Part B-20mg Pradigastat (LCQ908) Regimen | Part B- Pradigastat (LCQ908) Regimen- From Study A2212 | Part B-40 mg Pradigastat (LCQ908) | ||||||||
| Arm/Group Description | Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained. | Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | ||||||||
All Cause Mortality |
||||||||||||||||
| Part A-placebo of Pradigastat (LCQ908) Regimen | Part A-20mg Pradigastat (LCQ908) Regimen | Part A-40mg Pradigastat (LCQ908) Regimen | Part A: Pradigastat (LCQ908) Regimen- From Study A2212 | Part B-placebo of Pradigastat (LCQ908) Regimen | Part B-20mg Pradigastat (LCQ908) Regimen | Part B- Pradigastat (LCQ908) Regimen- From Study A2212 | Part B-40 mg Pradigastat (LCQ908) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Part A-placebo of Pradigastat (LCQ908) Regimen | Part A-20mg Pradigastat (LCQ908) Regimen | Part A-40mg Pradigastat (LCQ908) Regimen | Part A: Pradigastat (LCQ908) Regimen- From Study A2212 | Part B-placebo of Pradigastat (LCQ908) Regimen | Part B-20mg Pradigastat (LCQ908) Regimen | Part B- Pradigastat (LCQ908) Regimen- From Study A2212 | Part B-40 mg Pradigastat (LCQ908) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/11 (9.1%) | 6/12 (50%) | 2/10 (20%) | 2/5 (40%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| ANAEMIA | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| CORONARY ARTERY STENOSIS | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| PANCREATITIS | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 2/5 (40%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| PANCREATITIS ACUTE | 1/11 (9.1%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| GASTROENTERITIS | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| POSTOPERATIVE WOUND INFECTION | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Investigations | ||||||||||||||||
| ASPARTATE AMINOTRANSFERASE INCREASED | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| DEHYDRATION | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| DIABETES MELLITUS INADEQUATE CONTROL | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| HYPOGLYCAEMIA | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| MALNUTRITION | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Part A-placebo of Pradigastat (LCQ908) Regimen | Part A-20mg Pradigastat (LCQ908) Regimen | Part A-40mg Pradigastat (LCQ908) Regimen | Part A: Pradigastat (LCQ908) Regimen- From Study A2212 | Part B-placebo of Pradigastat (LCQ908) Regimen | Part B-20mg Pradigastat (LCQ908) Regimen | Part B- Pradigastat (LCQ908) Regimen- From Study A2212 | Part B-40 mg Pradigastat (LCQ908) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/11 (100%) | 12/12 (100%) | 10/10 (100%) | 5/5 (100%) | 4/5 (80%) | 3/6 (50%) | 3/4 (75%) | 0/4 (0%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| ANAEMIA | 1/11 (9.1%) | 1/12 (8.3%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| CARDIAC FAILURE | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Congenital, familial and genetic disorders | ||||||||||||||||
| ABNORMAL PALMAR/PLANTAR CREASES | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 1/4 (25%) | 0/4 (0%) | ||||||||
| Ear and labyrinth disorders | ||||||||||||||||
| EAR PAIN | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| VERTIGO POSITIONAL | 1/11 (9.1%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| ABDOMINAL DISCOMFORT | 1/11 (9.1%) | 2/12 (16.7%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| ABDOMINAL DISTENSION | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| ABDOMINAL PAIN | 2/11 (18.2%) | 1/12 (8.3%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 1/6 (16.7%) | 1/4 (25%) | 0/4 (0%) | ||||||||
| ABDOMINAL PAIN UPPER | 0/11 (0%) | 0/12 (0%) | 2/10 (20%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| CONSTIPATION | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| DIARRHOEA | 8/11 (72.7%) | 11/12 (91.7%) | 5/10 (50%) | 4/5 (80%) | 2/5 (40%) | 1/6 (16.7%) | 3/4 (75%) | 0/4 (0%) | ||||||||
| DYSPEPSIA | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| FAECAL INCONTINENCE | 1/11 (9.1%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| FOOD POISONING | 1/11 (9.1%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 1/5 (20%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| GASTRITIS | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| NAUSEA | 2/11 (18.2%) | 4/12 (33.3%) | 3/10 (30%) | 2/5 (40%) | 2/5 (40%) | 2/6 (33.3%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| PANCREATITIS | 0/11 (0%) | 2/12 (16.7%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| PANCREATITIS ACUTE | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| STEATORRHOEA | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| TONGUE CYST | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| VOMITING | 1/11 (9.1%) | 2/12 (16.7%) | 1/10 (10%) | 1/5 (20%) | 1/5 (20%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| General disorders | ||||||||||||||||
| FATIGUE | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| NON-CARDIAC CHEST PAIN | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| THIRST | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| VESSEL PUNCTURE SITE INDURATION | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| BRONCHITIS | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| CYSTITIS | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| GASTROENTERITIS | 1/11 (9.1%) | 2/12 (16.7%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| INFLUENZA | 6/11 (54.5%) | 2/12 (16.7%) | 2/10 (20%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| LUNG INFECTION | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| NASOPHARYNGITIS | 4/11 (36.4%) | 4/12 (33.3%) | 0/10 (0%) | 1/5 (20%) | 2/5 (40%) | 1/6 (16.7%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| PNEUMONIA | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| POST PROCEDURAL INFECTION | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| RESPIRATORY TRACT INFECTION | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| SINUSITIS | 1/11 (9.1%) | 2/12 (16.7%) | 1/10 (10%) | 1/5 (20%) | 1/5 (20%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| UPPER RESPIRATORY TRACT INFECTION | 1/11 (9.1%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 1/5 (20%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| URINARY TRACT INFECTION | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| VAGINAL INFECTION | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| VULVOVAGINAL MYCOTIC INFECTION | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| CONTUSION | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| FALL | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| FIBULA FRACTURE | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| LIGAMENT RUPTURE | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| MUSCLE STRAIN | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| POST PROCEDURAL INFLAMMATION | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| WOUND | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Investigations | ||||||||||||||||
| CARDIAC MURMUR | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| CAROTID BRUIT | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| WEIGHT DECREASED | 1/11 (9.1%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| DECREASED APPETITE | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| GOUT | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| HYPOGLYCAEMIA | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| HYPOKALAEMIA | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| VITAMIN B COMPLEX DEFICIENCY | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| VITAMIN D DEFICIENCY | 0/11 (0%) | 2/12 (16.7%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| BACK PAIN | 1/11 (9.1%) | 1/12 (8.3%) | 2/10 (20%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| MUSCULOSKELETAL PAIN | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 1/5 (20%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| MYALGIA | 1/11 (9.1%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| NECK PAIN | 0/11 (0%) | 1/12 (8.3%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| OSTEOARTHRITIS | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| PAIN IN EXTREMITY | 1/11 (9.1%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 1/5 (20%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| ROTATOR CUFF SYNDROME | 1/11 (9.1%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| SYNOVIAL CYST | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| TENDONITIS | 1/11 (9.1%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| APHONIA | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| DIZZINESS | 1/11 (9.1%) | 1/12 (8.3%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 1/6 (16.7%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| HEADACHE | 1/11 (9.1%) | 2/12 (16.7%) | 2/10 (20%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| MIGRAINE | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 1/5 (20%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| PARAESTHESIA | 0/11 (0%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| RESTLESS LEGS SYNDROME | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| SCIATICA | 0/11 (0%) | 0/12 (0%) | 2/10 (20%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| SYNCOPE | 1/11 (9.1%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Psychiatric disorders | ||||||||||||||||
| AGITATION | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| DEPRESSED MOOD | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| INSOMNIA | 0/11 (0%) | 1/12 (8.3%) | 1/10 (10%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| STRESS | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Reproductive system and breast disorders | ||||||||||||||||
| DYSMENORRHOEA | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| ERECTILE DYSFUNCTION | 0/11 (0%) | 1/12 (8.3%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| PREMATURE MENOPAUSE | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 1/4 (25%) | 0/4 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| COUGH | 1/11 (9.1%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| DYSPNOEA | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| PHARYNGEAL INFLAMMATION | 1/11 (9.1%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| PNEUMOTHORAX | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| RHINORRHOEA | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| ALOPECIA | 1/11 (9.1%) | 0/12 (0%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| PSORIASIS | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| RASH | 0/11 (0%) | 2/12 (16.7%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| XANTHOMA | 0/11 (0%) | 1/12 (8.3%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| Vascular disorders | ||||||||||||||||
| AORTIC ANEURYSM | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| HOT FLUSH | 0/11 (0%) | 0/12 (0%) | 0/10 (0%) | 0/5 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/4 (0%) | 0/4 (0%) | ||||||||
| HYPERTENSION | 0/11 (0%) | 2/12 (16.7%) | 1/10 (10%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||
Limitations/Caveats
As the anticipated benefit from the continued participation of patients in 18 month extension (Part B) was not supported by results of the December 2014 interim analysis, Novartis decided to terminate the Part B to be effective as of May 31, 2015.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
| trialandresults.registries@novartis.com |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01589237
Other Study ID Numbers:
- CLCQ908B2305
- 2012-000802-32
First Posted:
May 1, 2012
Last Update Posted:
Nov 15, 2016
Last Verified:
Sep 1, 2016