Trial Outcomes & Findings for Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure (NCT NCT01910389)
NCT ID: NCT01910389
Last Updated: 2015-05-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject
Results posted on
2015-05-04
Participant Flow
Participant milestones
| Measure |
Tadalafil
Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
|
Placebo
Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
8
|
Reasons for withdrawal
| Measure |
Tadalafil
Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
|
Placebo
Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Study Closed
|
13
|
8
|
Baseline Characteristics
Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure
Baseline characteristics by cohort
| Measure |
Tadalafil
n=15 Participants
Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
|
Placebo
n=8 Participants
Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
62.6 years
n=5 Participants
|
63.3 years
n=7 Participants
|
62.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subjectPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subjectPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subjectPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subjectPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subjectPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subjectPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subjectPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to 3 monthsPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to 3 monthsPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to 18 monthsPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to 18 monthsPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to 18 monthsPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to 18 monthsPopulation: Trial was terminated early. Data for outcome not obtained.
Outcome measures
Outcome data not reported
Adverse Events
Tadalafil
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tadalafil
n=15 participants at risk
Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
|
Placebo
n=8 participants at risk
Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
|
|---|---|---|
|
Cardiac disorders
CHF EXACERBATION
|
0.00%
0/15 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
12.5%
1/8 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
Cardiac disorders
CHF EXACERBATION, DYSPNEA
|
0.00%
0/15 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
12.5%
1/8 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
Cardiac disorders
CONGESTIVE HEART FAILURE
|
6.7%
1/15 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
Cardiac disorders
HOSPITALIZATION FOR DECOMPENSATED HEART FAILURE
|
6.7%
1/15 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
General disorders
ER ADMISSION; NOSEBLEED
|
6.7%
1/15 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
Infections and infestations
SEPSIS
|
6.7%
1/15 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
Other adverse events
| Measure |
Tadalafil
n=15 participants at risk
Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
|
Placebo
n=8 participants at risk
Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
|
|---|---|---|
|
Gastrointestinal disorders
DIARRHEA
|
6.7%
1/15 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
Vascular disorders
FLUSHING
|
6.7%
1/15 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
Nervous system disorders
HEADACHE
|
13.3%
2/15 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
6.7%
1/15 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
Psychiatric disorders
INSOMNIA
|
6.7%
1/15 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
General disorders
METALLIC TASTE TO FOOD
|
6.7%
1/15 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
Cardiac disorders
PALPITATIONS
|
6.7%
1/15 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
|
Gastrointestinal disorders
STOMACH UPSET
|
6.7%
1/15 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
0.00%
0/8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 3 years per subject
If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place