Trial Outcomes & Findings for 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (NCT NCT01451827)
NCT ID: NCT01451827
Last Updated: 2018-09-27
Results Overview
The primary endpoint was percent change from baseline in TKV at Week 3. Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
178 participants
Primary outcome timeframe
Baseline to Week 3
Results posted on
2018-09-27
Participant Flow
The trial was conducted in 177 participants at 41 trial states in the United States.
Participants entered a screening period within 4 weeks of being randomized (1:1:1:1) to one of four treatment groups. 178 is the number of subjects who enrolled due to informed consent, 177 is the number of subjects who were assigned to each treatment group.
Participant milestones
| Measure |
Tolvaptan Modifed Release (MR) 50 mg
Tolvaptan MR 50 mg capsule and 2 placebo immediate release (IR) tablets (morning) and 1 placebo IR tablet (evening)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan MR 80 mg
Tolvaptan MR 80 mg capsule and 2 placebo immediate release (IR) tablets (morning) and 1 placebo IR tablet (evening)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan Immediate Release (IR) 60/30 mg
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (morning) and 1 tolvaptan IR 30-mg tablet (evening)
Tolvaptan IR: 60/30 mg capsules
Placebo: tablet
|
Placebo
Placebo MR capsule and 2 placebo IR tablets (morning) and 1 placebo IR tablet (evening)
Placebo: tablet
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
44
|
43
|
|
Overall Study
COMPLETED
|
42
|
40
|
42
|
39
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
2
|
4
|
Reasons for withdrawal
| Measure |
Tolvaptan Modifed Release (MR) 50 mg
Tolvaptan MR 50 mg capsule and 2 placebo immediate release (IR) tablets (morning) and 1 placebo IR tablet (evening)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan MR 80 mg
Tolvaptan MR 80 mg capsule and 2 placebo immediate release (IR) tablets (morning) and 1 placebo IR tablet (evening)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan Immediate Release (IR) 60/30 mg
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (morning) and 1 tolvaptan IR 30-mg tablet (evening)
Tolvaptan IR: 60/30 mg capsules
Placebo: tablet
|
Placebo
Placebo MR capsule and 2 placebo IR tablets (morning) and 1 placebo IR tablet (evening)
Placebo: tablet
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
1
|
|
Overall Study
Protocol deviation
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
2
|
|
Overall Study
Participant met withdrawal criteria
|
0
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
Baseline Characteristics
8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Baseline characteristics by cohort
| Measure |
Tolvaptan MR 50 mg
n=45 Participants
Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (morning) and 1 placebo IR tablet (evening)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan MR 80 mg
n=45 Participants
Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (morning) and 1 placebo IR tablet (evening)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan IR 60/30 mg
n=44 Participants
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (morning) and 1 tolvaptan IR 30-mg tablet (PM)
Tolvaptan IR: 60/30 mg capsules
Placebo: tablet
|
Placebo
n=43 Participants
Placebo MR capsule and 2 placebo IR tablets (evening) and 1 placebo IR tablet (morning)
Placebo: tablet
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
34.0 years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 3Population: Participants who were randomized and had baseline and post-baseline observations in the total renal volume.
The primary endpoint was percent change from baseline in TKV at Week 3. Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.
Outcome measures
| Measure |
Tolvaptan MR 50 mg
n=41 Participants
Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan MR 80 mg
n=43 Participants
Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan IR 60/30 mg
n=41 Participants
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (AM) and 1 tolvaptan IR 30-mg tablet (PM)
Tolvaptan IR: 60/30 mg capsules
Placebo: tablet
|
Placebo
n=39 Participants
Placebo MR capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Placebo: tablet
|
|---|---|---|---|---|
|
Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3
|
-2.46 Percentage change
Standard Deviation 4.40
|
-2.55 Percentage change
Standard Deviation 3.85
|
-1.17 Percentage change
Standard Deviation 4.52
|
0.09 Percentage change
Standard Deviation 5.31
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Participants who were randomized and had baseline and post-baseline observations in the total renal volume.
The ADPKD-UIS was a self-administered questionnaire designed to measure ADPKD-related urinary symptoms in participants with ADPKD. This instrument contained 11 items in 3 domains (Urinary Frequency, Urinary Urgency, and Nocturia). Each item was scored using a scale of 1 to 5 (a higher score indicated increased difficulty/extremely bothered). The maximum total score is 55; 1: not difficult/not bothered at all; 55: extremely difficult/extremely bothered.
Outcome measures
| Measure |
Tolvaptan MR 50 mg
n=39 Participants
Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan MR 80 mg
n=40 Participants
Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan IR 60/30 mg
n=42 Participants
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (AM) and 1 tolvaptan IR 30-mg tablet (PM)
Tolvaptan IR: 60/30 mg capsules
Placebo: tablet
|
Placebo
n=38 Participants
Placebo MR capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Placebo: tablet
|
|---|---|---|---|---|
|
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)
Urinary Frequency
|
0.74 Unit on a scale
Standard Deviation 0.94
|
0.82 Unit on a scale
Standard Deviation 0.83
|
0.99 Unit on a scale
Standard Deviation 0.78
|
0.10 Unit on a scale
Standard Deviation 0.35
|
|
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)
Urinary Urgency
|
0.69 Unit on a scale
Standard Deviation 0.96
|
0.66 Unit on a scale
Standard Deviation 0.77
|
1.01 Unit on a scale
Standard Deviation 0.95
|
0.05 Unit on a scale
Standard Deviation 0.30
|
|
Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)
Nocturia
|
0.97 Unit on a scale
Standard Deviation 1.28
|
1.15 Unit on a scale
Standard Deviation 0.89
|
1.36 Unit on a scale
Standard Deviation 1.12
|
0.11 Unit on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: The core patient population for all efficacy analyses was based on the intent-to-treat (ITT) population which consisted of all randomized participants who take at least one dose of study drug. Observed Cases (OC) dataset within treatment period was defined as the data observed at study specified visits while subjects are taking study drug.
Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.
Outcome measures
| Measure |
Tolvaptan MR 50 mg
n=20 Participants
Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan MR 80 mg
n=22 Participants
Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan IR 60/30 mg
n=21 Participants
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (AM) and 1 tolvaptan IR 30-mg tablet (PM)
Tolvaptan IR: 60/30 mg capsules
Placebo: tablet
|
Placebo
n=24 Participants
Placebo MR capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Placebo: tablet
|
|---|---|---|---|---|
|
Percent Change From Baseline in TKV at Week 8.
|
-2.04 Percentage change
Standard Deviation 3.87
|
-2.02 Percentage change
Standard Deviation 3.54
|
-0.08 Percentage change
Standard Deviation 7.31
|
2.13 Percentage change
Standard Deviation 7.99
|
Adverse Events
Tolvaptan MR 50 mg
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Tolvaptan MR 80 mg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Tolvaptan IR 60/30 mg
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tolvaptan MR 50 mg
n=45 participants at risk
Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan MR 80 mg
n=44 participants at risk
Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan IR 60/30 mg
n=44 participants at risk
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (AM) and 1 tolvaptan IR 30-mg tablet (PM)
Tolvaptan IR: 60/30 mg capsules
Placebo: tablet
|
Placebo
n=42 participants at risk
Placebo MR capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Placebo: tablet
|
|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
1/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.3%
1/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Investigations
Blood creatinine increased
|
2.2%
1/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.4%
1/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.3%
1/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Renal and urinary disorders
Renal pain
|
2.2%
1/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
Other adverse events
| Measure |
Tolvaptan MR 50 mg
n=45 participants at risk
Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan MR 80 mg
n=44 participants at risk
Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Tolvaptan MR: 50/80 mg capsules
Placebo: tablet
|
Tolvaptan IR 60/30 mg
n=44 participants at risk
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (AM) and 1 tolvaptan IR 30-mg tablet (PM)
Tolvaptan IR: 60/30 mg capsules
Placebo: tablet
|
Placebo
n=42 participants at risk
Placebo MR capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
Placebo: tablet
|
|---|---|---|---|---|
|
Renal and urinary disorders
Polyuria
|
24.4%
11/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
25.0%
11/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
29.5%
13/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
7.1%
3/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Gastrointestinal disorders
Dry mouth
|
15.6%
7/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
15.9%
7/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
4.5%
2/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.4%
1/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.3%
1/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
4.5%
2/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
9.5%
4/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
General disorders
Fatigue
|
6.7%
3/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
4.5%
2/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
13.6%
6/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.4%
1/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
General disorders
Thirst
|
33.3%
15/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
34.1%
15/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
43.2%
19/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
14.3%
6/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Metabolism and nutrition disorders
Polydipsia
|
15.6%
7/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
13.6%
6/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
11.4%
5/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
4.8%
2/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.3%
1/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
15.9%
7/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.4%
1/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Renal and urinary disorders
Nocturia
|
31.1%
14/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
31.8%
14/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
40.9%
18/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
7.1%
3/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Renal and urinary disorders
Pollakuria
|
17.8%
8/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
20.5%
9/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
27.3%
12/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
7.1%
3/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
3/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.3%
1/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
0.00%
0/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.4%
1/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Renal and urinary disorders
Renal pain
|
2.2%
1/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
2.3%
1/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
4.5%
2/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
7.1%
3/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
|
Vascular disorders
Hypertension
|
4.4%
2/45 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
4.5%
2/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
6.8%
3/44 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
4.8%
2/42 • Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 7 days after the last dose of study medication.
Safety analysis set consisted of all participants who took at least one dose of study medication. Serious adverse events, non-serious adverse events, and deaths were analyzed using safety analysis population.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee Center may publish study results but ≥ 60 days prior to any public presentation, a copy is sent to Sponsor for review and Center can delay publication for 60 days to permit Sponsor to protect its intellectual property rights or confidential information contained within the publication. The first publication is a joint publication, if Center is part of a multi-center study. Center is free to publish, if there is no multi-center publication within 18 months of completion/ termination of study.
- Publication restrictions are in place
Restriction type: OTHER