Trial Outcomes & Findings for Tolvaptan for Ascites in Cirrhotic Patients (NCT NCT01292304)
NCT ID: NCT01292304
Last Updated: 2015-07-27
Results Overview
Increase in number of therapeutic paracentesis (removal of \> 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
Week 12
Results posted on
2015-07-27
Participant Flow
Participant milestones
| Measure |
Tolvaptan
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolvaptan for Ascites in Cirrhotic Patients
Baseline characteristics by cohort
| Measure |
Tolvaptan
n=10 Participants
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
62.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Increase in number of therapeutic paracentesis (removal of \> 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing
Outcome measures
| Measure |
Tolvaptan
n=10 Participants
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg
|
|---|---|
|
Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)
|
0 participants
|
PRIMARY outcome
Timeframe: 12 weeks of study drugThis outcome will provide the number of subjects with a weight increase of \> 2kg from baseline (worsening ascites)
Outcome measures
| Measure |
Tolvaptan
n=10 Participants
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg
|
|---|---|
|
Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)
|
7 participants
|
SECONDARY outcome
Timeframe: 12 weeksNumber of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing
Outcome measures
| Measure |
Tolvaptan
n=10 Participants
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg
|
|---|---|
|
Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksNumber of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium \>130 mmol/L and \<135 mmol/L
Outcome measures
| Measure |
Tolvaptan
n=10 Participants
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg
|
|---|---|
|
Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)
|
1 participants
|
SECONDARY outcome
Timeframe: 12 weeks of study drugThis outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.
Outcome measures
| Measure |
Tolvaptan
n=10 Participants
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg
|
|---|---|
|
Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)
|
27 Days
Interval 8.0 to 57.0
|
Adverse Events
Tolvaptan
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tolvaptan
n=10 participants at risk
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.0%
1/10 • Number of events 2 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
Other adverse events
| Measure |
Tolvaptan
n=10 participants at risk
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Nervous system disorders
Asterixis
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • Number of events 2 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Gastrointestinal disorders
Bloating
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
General disorders
Cold Sensitivity
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 2 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
General disorders
Dry mouth
|
20.0%
2/10 • Number of events 2 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Blood and lymphatic system disorders
Elevated serum creatinine
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Blood and lymphatic system disorders
Hyopmagnesemia
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Blood and lymphatic system disorders
Hypernatrimia
|
20.0%
2/10 • Number of events 2 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Cardiac disorders
Hypertension
|
10.0%
1/10 • Number of events 2 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
General disorders
Lethargy
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Lung pain
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Skin and subcutaneous tissue disorders
Mouth soreness
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 2 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Nervous system disorders
Nighttime blackouts
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic chest pain
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
General disorders
Polydipsia
|
80.0%
8/10 • Number of events 8 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Metabolism and nutrition disorders
Polyphagia
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Renal and urinary disorders
Polyuria
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Gastrointestinal disorders
Stomach cramps
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Psychiatric disorders
Stress
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
|
Nervous system disorders
Vertigo
|
10.0%
1/10 • Number of events 1 • Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place