A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01548287
Collaborator
(none)
164
13
4
9
12.6
1.4
Study Details
Study Description
Brief Summary
This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
A Phase IIa Safety and Tolerability Study to Investigate the Effect on Sleep of 3 Doses of AZD5213 and Placebo in Patients with Mild Alzheimer's Disease and Mild Cognitive Impairment During 4 Weeks of Treatment, Designed as a Randomized, Double-Blind, Multi-Center, Parallel Group, Placebo-Controlled Study
Study Design
Study Type:
Interventional
Actual Enrollment
:
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase IIa Safety and Tolerability Study to Investigate the Effect on Sleep of 3 Doses of AZD5213 and Placebo in Patients With Mild Alzheimer's Disease and Mild Cognitive Impairment During 4 Weeks of Treatment, Placebo-Controlled
Study Start Date
:
Apr 1, 2012
Actual Primary Completion Date
:
Jan 1, 2013
Actual Study Completion Date
:
Jan 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AZD5213 doseA AZD5213 doseA daily |
Drug: AZD5213
AZD5213 doseA daily
|
| Experimental: AZD5213 doseB AZD 5213 doseB daily |
Drug: AZD5213
AZD5213 doseB daily
|
| Experimental: AZD5213 doseC AZD5213 doseC daily |
Drug: AZD5213
AZD5213 doseC daily
|
| Placebo Comparator: Placebo Placebo daily |
Other: Placebo
Placebo tablet daily
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement. [Baseline and Week 4.]
Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.
Secondary Outcome Measures
- Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements. [Baseline and Week 4.]
- Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements. [Baseline and Week 4.]
- Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording. [Baseline and Week 4.]
Change from baseline in night total sleep time after 4 weeks of treatment: assessed if valid baseline and week 4 actigraphy data
- Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording. [Baseline and Week 4.]
Change from baseline in latency of persistent sleep after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data
- Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording. [Baseline and Week 4.]
Change from baseline in sleep efficiency after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patient and study partner to sign informed consent before initiation of any study-related procedures.
-
Clinical diagnosis of Alzheimers (AD) or mild cognitive impairment (MCI) disease.
-
Single caregiver for at least 6 months prior to Screening, capable of accompanying the patient on clinic visits as needed. The caregiver must either be living with or visiting the patient at least 10 hours per week, split over multiple (at least 2) days, for the duration of the study.
-
Single study partner, for at least several months prior to Screening, capable of accompanying the patient on clinic visits as needed. The study partner must either be living with or visiting the patient at least 3 days per week for the duration of the study.
-
A body mass index (BMI=weight/height2) of 18 kg/m2 to 32 kg/m2.
Exclusion Criteria:
-
Significant neurological disease or dementia other than AD or MCI.
-
Current episode or symptoms of major depressive disorder or other major psychiatric disorder.
-
History of self-reported sleep duration of less than 4 hours per night or less than 4 hours average total sleep time per night during Baseline PSG assessment.
-
History or present symptoms of a sleeping disorder such as sleep apnea.
-
History of cancer in the last 5 years.
-
Use of anti-AD drugs (including off-label drugs and herbal medications) with the exception of donepezil, memantine, and/or rivastigmine transdermal system, as monotherapy or in combination in the following conditions: treatment with donepezil (5 mg to 10 mg daily), memantine, and/or rivastigmine transdermal system or combination regimens for at least 3 months and a stable dose(s) for the last 2 months prior to randomization is allowed.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Phoenix | Arizona | United States | |
| 2 | Research Site | Indio | California | United States | |
| 3 | Research Site | Lomita | California | United States | |
| 4 | Research Site | San Francisco | California | United States | |
| 5 | Research Site | Delray Beach | Florida | United States | |
| 6 | Research Site | Fort Myers | Florida | United States | |
| 7 | Research Site | Hallandale Beach | Florida | United States | |
| 8 | Research Site | Orlando | Florida | United States | |
| 9 | Research Site | Tampa | Florida | United States | |
| 10 | Research Site | Eatontown | New Jersey | United States | |
| 11 | Research Site | Brooklyn | New York | United States | |
| 12 | Research Site | New York | New York | United States | |
| 13 | Research Site | Salt Lake City | Utah | United States |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Robert C. Alexander, MD, AstraZeneca Research & Development, Neuroscience iMed, 141 Portland Street, Cambridge, MA 02139
- Study Director: Roza Hayduk, MD, Quintiles 10201 Wateridge Circle San Diego, CA
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01548287
Other Study ID Numbers:
- D3030C00005
First Posted:
Mar 8, 2012
Last Update Posted:
Feb 7, 2017
Last Verified:
Dec 1, 2016
Keywords provided by AstraZeneca
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 164 subjects signed informed consent and 83 failed to qualify at the first screening visit for participation in the study. |
| Arm/Group Title | AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo | Screening Only |
|---|---|---|---|---|---|
| Arm/Group Description | AZD5213 AZD 0.5 mg daily | AZD 5213 2.0 mg daily | AZD5213 6.0 mg daily | Placebo daily | Screening period only, not randomized |
| Period Title: Screening | |||||
| STARTED | 19 | 22 | 20 | 20 | 83 |
| COMPLETED | 19 | 22 | 20 | 20 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 83 |
| Period Title: Screening | |||||
| STARTED | 19 | 22 | 20 | 20 | 0 |
| COMPLETED | 19 | 20 | 13 | 20 | 0 |
| NOT COMPLETED | 0 | 2 | 7 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo | Total |
|---|---|---|---|---|---|
| Arm/Group Description | AZD5213 AZD 0.5 mg daily | AZD 5213 2.0 mg daily | AZD5213 6.0 mg daily | Placebo daily | Total of all reporting groups |
| Overall Participants | 19 | 22 | 20 | 20 | 81 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
66.1
(8.02)
|
65.1
(8.04)
|
69.3
(10.32)
|
64.2
(7.62)
|
66.1
(8.62)
|
| Gender (Count of Participants) | |||||
| Female |
12
63.2%
|
16
72.7%
|
13
65%
|
15
75%
|
56
69.1%
|
| Male |
7
36.8%
|
6
27.3%
|
7
35%
|
5
25%
|
25
30.9%
|
| Mini-Mental State Examination (Scores on scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Scores on scale] |
27.2
(1.38)
|
27.0
(2.01)
|
26.1
(1.62)
|
27.0
(1.88)
|
26.8
(1.77)
|
| Alzheimers disease (AD)/Mild cognitive impairment (MCI) (Number) [Number] | |||||
| AD |
3
15.8%
|
6
27.3%
|
5
25%
|
5
25%
|
19
23.5%
|
| MCI |
16
84.2%
|
16
72.7%
|
15
75%
|
15
75%
|
62
76.5%
|
| Concomitant donepezil administration (Number) [Number] | |||||
| Yes |
2
10.5%
|
1
4.5%
|
3
15%
|
3
15%
|
9
11.1%
|
| No |
17
89.5%
|
21
95.5%
|
17
85%
|
17
85%
|
72
88.9%
|
Outcome Measures
| Title | Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement. |
|---|---|
| Description | Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement. |
| Time Frame | Baseline and Week 4. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary analysis set |
| Arm/Group Title | AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD5213 AZD 0.5 mg daily | AZD 5213 2.0 mg daily | AZD5213 6.0 mg daily | Placebo daily |
| Measure Participants | 19 | 20 | 13 | 20 |
| Least Squares Mean (90% Confidence Interval) [Minutes] |
6.43
|
-12.53
|
-19.41
|
14.48
|
| Title | Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements. |
|---|---|
| Description | |
| Time Frame | Baseline and Week 4. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary analysis set |
| Arm/Group Title | AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD5213 AZD 0.5 mg daily | AZD 5213 2.0 mg daily | AZD5213 6.0 mg daily | Placebo daily |
| Measure Participants | 19 | 20 | 13 | 20 |
| Least Squares Mean (90% Confidence Interval) [% change] |
0.08
|
-1.51
|
-2.82
|
0.96
|
| Title | Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements. |
|---|---|
| Description | |
| Time Frame | Baseline and Week 4. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary analysis set |
| Arm/Group Title | AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD5213 AZD 0.5 mg daily | AZD 5213 2.0 mg daily | AZD5213 6.0 mg daily | Placebo daily |
| Measure Participants | 19 | 20 | 13 | 20 |
| Least Squares Mean (90% Confidence Interval) [Rank transformed duration (minutes)] |
-2.23
|
14.48
|
-5.84
|
-5.68
|
| Title | Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording. |
|---|---|
| Description | Change from baseline in night total sleep time after 4 weeks of treatment: assessed if valid baseline and week 4 actigraphy data |
| Time Frame | Baseline and Week 4. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subset of Primary Analysis Set with valid actigraphy data |
| Arm/Group Title | AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD5213 AZD 0.5 mg daily | AZD 5213 2.0 mg daily | AZD5213 6.0 mg daily | Placebo daily |
| Measure Participants | 17 | 19 | 11 | 17 |
| Least Squares Mean (90% Confidence Interval) [Minutes] |
7.07
|
-12.42
|
-18.97
|
-7.51
|
| Title | Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording. |
|---|---|
| Description | Change from baseline in latency of persistent sleep after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data |
| Time Frame | Baseline and Week 4. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subset of Primary Analysis Set with valid actigraphy data |
| Arm/Group Title | AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD5213 AZD 0.5 mg daily | AZD 5213 2.0 mg daily | AZD5213 6.0 mg daily | Placebo daily |
| Measure Participants | 17 | 19 | 11 | 17 |
| Least Squares Mean (90% Confidence Interval) [Minutes] |
1.77
|
9.84
|
-6.85
|
2.70
|
| Title | Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording. |
|---|---|
| Description | Change from baseline in sleep efficiency after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data |
| Time Frame | Baseline and Week 4. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subset of Primary Analysis Population with valid actigraphy data |
| Arm/Group Title | AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD5213 AZD 0.5 mg daily | AZD 5213 2.0 mg daily | AZD5213 6.0 mg daily | Placebo daily |
| Measure Participants | 17 | 19 | 11 | 17 |
| Least Squares Mean (90% Confidence Interval) [% (efficiency=% of time asleep)] |
-0.05
|
-3.20
|
-1.92
|
-1.83
|
Adverse Events
| Time Frame | From first dose of study drug through the follow-up (up to 38 days total) | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo | ||||
| Arm/Group Description | AZD5213 AZD 0.5 mg daily | AZD 5213 2.0 mg daily | AZD5213 6.0 mg daily | Placebo daily | ||||
All Cause Mortality |
||||||||
| AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/19 (0%) | 0/22 (0%) | 1/20 (5%) | 0/20 (0%) | ||||
| Nervous system disorders | ||||||||
| Transient ischemic attack | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| AZD5213 Dose A | AZD5213 Dose B | AZD5213 Dose C | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/19 (31.6%) | 11/22 (50%) | 13/20 (65%) | 8/20 (40%) | ||||
| Ear and labyrinth disorders | ||||||||
| Ear pruritus | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Hyperacusis | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Vertigo | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Nausea | 1/19 (5.3%) | 1 | 1/22 (4.5%) | 1 | 2/20 (10%) | 2 | 1/20 (5%) | 1 |
| Dyspesia | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 2/20 (10%) | 2 | 0/20 (0%) | 0 |
| Diarrhoea | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 1/20 (5%) | 1 |
| Constipation | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Toothache | 1/19 (5.3%) | 1 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Vomiting | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Dental caries | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 1/20 (5%) | 1 |
| General disorders | ||||||||
| Feeling hot | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Irritability | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Pyrexia | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Thirst | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Malaise | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 1/20 (5%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Fall | 1/19 (5.3%) | 1 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Contusion | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Excoriation | 1/19 (5.3%) | 1 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Laceration | 1/19 (5.3%) | 1 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Muscle strain | 1/19 (5.3%) | 1 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Investigations | ||||||||
| Blood pressure increased | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 1/20 (5%) | 1 |
| Heart rate increased | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 1/20 (5%) | 1 |
| Metabolism and nutrition disorders | ||||||||
| Fluid retention | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 1/20 (5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Muscle spasms | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Osteoporosis | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Osteoarthritis | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 1/20 (5%) | 1 |
| Nervous system disorders | ||||||||
| Headache | 1/19 (5.3%) | 1 | 4/22 (18.2%) | 4 | 5/20 (25%) | 6 | 2/20 (10%) | 2 |
| Dizziness | 0/19 (0%) | 0 | 2/22 (9.1%) | 3 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Poor quality sleep | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 1/20 (5%) | 1 |
| Balance disorder | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Hypoasthesia | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Tremor | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Cognitive disorder | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 1/20 (5%) | 1 |
| Psychiatric disorders | ||||||||
| Insomnia | 0/19 (0%) | 0 | 4/22 (18.2%) | 4 | 8/20 (40%) | 9 | 0/20 (0%) | 0 |
| Abnormal dreams | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 1/20 (5%) | 1 | 1/20 (5%) | 1 |
| Libido increased | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Restlessness | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 2/20 (10%) | 2 | 0/20 (0%) | 0 |
| Confusional state | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Euphoric mood | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Hypnagogic hallucination | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Nightmare | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Paranoia | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Erection increased | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Nasal congestion | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 2/20 (10%) | 2 |
| Oropharyngeal pain | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 1/20 (5%) | 1 |
| Dry throat | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Dyspnoea | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Cough | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 1/20 (5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Night sweats | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 3/20 (15%) | 3 | 0/20 (0%) | 0 |
| Hyperhidrosis | 0/19 (0%) | 0 | 1/22 (4.5%) | 1 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Pruritus | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 2 | 0/20 (0%) | 0 |
| Vascular disorders | ||||||||
| Hot flush | 0/19 (0%) | 0 | 1/22 (4.5%) | 2 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
| Hypertension | 1/19 (5.3%) | 1 | 0/22 (0%) | 0 | 0/20 (0%) | 0 | 0/20 (0%) | 0 |
| Orthostatic hypotension | 0/19 (0%) | 0 | 0/22 (0%) | 0 | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Joel Posener, MD |
|---|---|
| Organization | AstraZeneca Pharmaceuticals LP, Neuroscience iMed |
| Phone | |
| clinicaltrialtransparency@astrazeneca.net |
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01548287
Other Study ID Numbers:
- D3030C00005
First Posted:
Mar 8, 2012
Last Update Posted:
Feb 7, 2017
Last Verified:
Dec 1, 2016