Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT01237223
Collaborator
(none)
1,342
11
6
7
122
17.5
Study Details
Study Description
Brief Summary
The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure [msDBP] ≥ 95 mmHg and < 110 mmHg and mean sitting systolic blood pressure [msSBP] ≥ 140 mmHg ). This study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in Japan.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1342 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An 8-week Double-blind, Multicenter, Randomized, 6-arm, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in Patients With Essential Hypertension
Study Start Date
:
Oct 1, 2010
Actual Primary Completion Date
:
May 1, 2011
Actual Study Completion Date
:
May 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily. |
Drug: Placebo of Aliskiren
Aliskiren placebo tablet
Drug: Placebo of Amlodipine
Amlodipine placebo capsule
Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/2.5 mg placebo tablet
Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg placebo tablet
|
| Active Comparator: Aliskiren 150 mg In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. |
Drug: Aliskiren 150 mg
Aliskiren 150 mg tablet
Drug: Placebo of Amlodipine
Amlodipine placebo capsule
Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/2.5 mg placebo tablet
Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg placebo tablet
|
| Active Comparator: Amlodipine 2.5 mg In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. |
Drug: Amlodipine 2.5 mg
Amlodipine 2.5 mg capsule
Drug: Placebo of Aliskiren
Aliskiren placebo tablet
Drug: Placebo of Amlodipine
Amlodipine placebo capsule
Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/2.5 mg placebo tablet
Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg placebo tablet
|
| Active Comparator: Amlodipine 5 mg In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
Drug: Amlodipine 2.5 mg
Amlodipine 2.5 mg capsule
Drug: Placebo of Aliskiren
Aliskiren placebo tablet
Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/2.5 mg placebo tablet
Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg placebo tablet
|
| Experimental: Aliskiren/amlodipine 150/2.5 mg In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. |
Drug: Aliskiren/Amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/2.5 mg tablet
Drug: Placebo of Aliskiren
Aliskiren placebo tablet
Drug: Placebo of Amlodipine
Amlodipine placebo capsule
Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg placebo tablet
|
| Experimental: Aliskiren/amlodipine 150/5 mg In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
Drug: Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg tablet
Drug: Placebo of Aliskiren
Aliskiren placebo tablet
Drug: Placebo of Amlodipine
Amlodipine placebo capsule
Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/2.5 mg placebo tablet
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8) [Baseline, Week 8]
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
Secondary Outcome Measures
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8) [Baseline, Week 8]
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
- Percentage of Participants Achieving Blood Pressure Control at Endpoint [8 weeks]
Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.
- Percentage of Participants Achieving a Successful Response Rate [8 weeks]
The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.
- Number of Participants With Adverse Events, Serious Adverse Events and Death [8 weeks]
Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with essential hypertension (msDBP ≥ 95 mmHg and < 110 mmHg and msSBP ≥140 mmHg )
-
Outpatients
Exclusion Criteria:
-
Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
-
History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers
-
History or evidence of a secondary hypertension
Other protocol-defined inclusion/exclusion criteria applied
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigative Site | Aichi | Japan | ||
| 2 | Investigative Site | Ehime | Japan | ||
| 3 | Investigative Site | Fukuoka | Japan | ||
| 4 | Investigative Site | Hokkaido | Japan | ||
| 5 | Investigative Site | Hyogo | Japan | ||
| 6 | Investigative Site | Kanagawa | Japan | ||
| 7 | Investigative Site | Kyoto | Japan | ||
| 8 | Investigative Site | Okayama | Japan | ||
| 9 | Investigative Site | Osaka | Japan | ||
| 10 | Investigative Site | Saitama | Japan | ||
| 11 | Investigative Site | Tokyo | Japan |
Sponsors and Collaborators
- Novartis
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT01237223
Other Study ID Numbers:
- CSPA100A1301
First Posted:
Nov 9, 2010
Last Update Posted:
Jun 13, 2012
Last Verified:
May 1, 2012
Keywords provided by Novartis
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
| Period Title: Single Blind(Run-in Period, 4 Weeks) | ||||||
| STARTED | 1342 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 944 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 398 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Single Blind(Run-in Period, 4 Weeks) | ||||||
| STARTED | 153 | 157 | 158 | 158 | 159 | 159 |
| COMPLETED | 120 | 142 | 143 | 153 | 155 | 154 |
| NOT COMPLETED | 33 | 15 | 15 | 5 | 4 | 5 |
Baseline Characteristics
| Arm/Group Title | Placebo | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. | Total of all reporting groups |
| Overall Participants | 153 | 157 | 158 | 158 | 159 | 159 | 944 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
54.6
(8.35)
|
55.0
(9.96)
|
54.8
(10.25)
|
55.8
(10.05)
|
54.6
(11.11)
|
55.5
(9.86)
|
55.1
(9.96)
|
| Age, Customized (participants) [Number] | |||||||
| < 65 years |
128
83.7%
|
131
83.4%
|
129
81.6%
|
126
79.7%
|
125
78.6%
|
127
79.9%
|
766
81.1%
|
| >=65 years |
25
16.3%
|
26
16.6%
|
29
18.4%
|
32
20.3%
|
34
21.4%
|
32
20.1%
|
178
18.9%
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
45
29.4%
|
39
24.8%
|
45
28.5%
|
51
32.3%
|
51
32.1%
|
57
35.8%
|
288
30.5%
|
| Male |
108
70.6%
|
118
75.2%
|
113
71.5%
|
107
67.7%
|
108
67.9%
|
102
64.2%
|
656
69.5%
|
Outcome Measures
| Title | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8) |
|---|---|
| Description | Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate. |
| Time Frame | Baseline, Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication. |
| Arm/Group Title | Placebo | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
| Measure Participants | 153 | 157 | 158 | 158 | 159 | 159 |
| Least Squares Mean (Standard Error) [mm Hg] |
-5.21
(0.69)
|
-7.49
(0.68)
|
-9.46
(0.68)
|
-11.90
(0.68)
|
-12.40
(0.68)
|
-16.43
(0.68)
|
| Title | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8) |
|---|---|
| Description | Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate. |
| Time Frame | Baseline, Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication. |
| Arm/Group Title | Placebo | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
| Measure Participants | 153 | 157 | 158 | 158 | 159 | 159 |
| Least Squares Mean (Standard Error) [mm Hg] |
-4.57
(0.97)
|
-10.63
(0.96)
|
-13.16
(0.96)
|
-17.98
(0.96)
|
-18.15
(0.96)
|
-25.49
(0.96)
|
| Title | Percentage of Participants Achieving Blood Pressure Control at Endpoint |
|---|---|
| Description | Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg. |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication |
| Arm/Group Title | Placebo | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
| Measure Participants | 153 | 157 | 158 | 158 | 159 | 159 |
| Number [percentage of participants] |
16.3
10.7%
|
25.5
16.2%
|
32.9
20.8%
|
50.0
31.6%
|
45.9
28.9%
|
69.2
43.5%
|
| Title | Percentage of Participants Achieving a Successful Response Rate |
|---|---|
| Description | The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint. |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication |
| Arm/Group Title | Placebo | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
| Measure Participants | 153 | 157 | 158 | 158 | 159 | 159 |
| Number [percentage of participants] |
34.6
22.6%
|
46.5
29.6%
|
50.6
32%
|
70.3
44.5%
|
65.4
41.1%
|
86.2
54.2%
|
| Title | Number of Participants With Adverse Events, Serious Adverse Events and Death |
|---|---|
| Description | Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported. |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety set: All patients who received at least one dose of double-blind study medication. |
| Arm/Group Title | Placebo | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
| Measure Participants | 153 | 157 | 158 | 158 | 159 | 159 |
| Adverse Events |
62
40.5%
|
57
36.3%
|
50
31.6%
|
49
31%
|
57
35.8%
|
59
37.1%
|
| Serious Adverse Events |
0
0%
|
0
0%
|
2
1.3%
|
1
0.6%
|
0
0%
|
1
0.6%
|
| Death |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | Placebo (Double Blind) | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg | Placebo (Single-Blind run-in Period) | |||||||
| Arm/Group Description | In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. | In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in period (4 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily. | |||||||
All Cause Mortality |
||||||||||||||
| Placebo (Double Blind) | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg | Placebo (Single-Blind run-in Period) | ||||||||
| 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) | |||||||
Serious Adverse Events |
||||||||||||||
| Placebo (Double Blind) | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg | Placebo (Single-Blind run-in Period) | ||||||||
| 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 | 0/153 (0%) | 0/157 (0%) | 2/158 (1.3%) | 1/158 (0.6%) | 0/159 (0%) | 1/159 (0.6%) | 4/1342 (0.3%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Gastric ulcer | 0/153 (0%) | 0/157 (0%) | 1/158 (0.6%) | 0/158 (0%) | 0/159 (0%) | 0/159 (0%) | 0/1342 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Herpes zoster oticus | 0/153 (0%) | 0/157 (0%) | 0/158 (0%) | 1/158 (0.6%) | 0/159 (0%) | 0/159 (0%) | 0/1342 (0%) | |||||||
| Pneumonia | 0/153 (0%) | 0/157 (0%) | 1/158 (0.6%) | 0/158 (0%) | 0/159 (0%) | 0/159 (0%) | 0/1342 (0%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Pelvic fracture | 0/153 (0%) | 0/157 (0%) | 0/158 (0%) | 0/158 (0%) | 0/159 (0%) | 1/159 (0.6%) | 0/1342 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Hypertensive encephalopathy | 0/153 (0%) | 0/157 (0%) | 0/158 (0%) | 0/158 (0%) | 0/159 (0%) | 0/159 (0%) | 1/1342 (0.1%) | |||||||
| Putamen haemorrhage | 0/153 (0%) | 0/157 (0%) | 0/158 (0%) | 0/158 (0%) | 0/159 (0%) | 0/159 (0%) | 1/1342 (0.1%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Pneumothorax | 0/153 (0%) | 0/157 (0%) | 0/158 (0%) | 0/158 (0%) | 0/159 (0%) | 0/159 (0%) | 1/1342 (0.1%) | |||||||
| Vascular disorders | ||||||||||||||
| Hypertensive crisis | 0/153 (0%) | 0/157 (0%) | 0/158 (0%) | 0/158 (0%) | 0/159 (0%) | 0/159 (0%) | 1/1342 (0.1%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Placebo (Double Blind) | Aliskiren 150 mg | Amlodipine 2.5 mg | Amlodipine 5 mg | Aliskiren/Amlodipine 150/2.5 mg | Aliskiren/Amlodipine 150/5 mg | Placebo (Single-Blind run-in Period) | ||||||||
| 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 | 21/153 (13.7%) | 21/157 (13.4%) | 17/158 (10.8%) | 21/158 (13.3%) | 17/159 (10.7%) | 19/159 (11.9%) | 136/1342 (10.1%) | |||||||
| Infections and infestations | ||||||||||||||
| Nasopharyngitis | 11/153 (7.2%) | 17/157 (10.8%) | 14/158 (8.9%) | 19/158 (12%) | 16/159 (10.1%) | 16/159 (10.1%) | 81/1342 (6%) | |||||||
| Nervous system disorders | ||||||||||||||
| Headache | 12/153 (7.8%) | 5/157 (3.2%) | 3/158 (1.9%) | 2/158 (1.3%) | 1/159 (0.6%) | 3/159 (1.9%) | 59/1342 (4.4%) | |||||||
Limitations/Caveats
[Not Specified]
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 |
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT01237223
Other Study ID Numbers:
- CSPA100A1301
First Posted:
Nov 9, 2010
Last Update Posted:
Jun 13, 2012
Last Verified:
May 1, 2012