Trial Outcomes & Findings for Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi and PE5i (NCT NCT00750308)
NCT ID: NCT00750308
Last Updated: 2014-12-18
Results Overview
Beta cell function as measured during a frequently sampled IV glucose tolerance test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
3 hours
Results posted on
2014-12-18
Participant Flow
Participant milestones
| Measure |
Tadalafil, Ramipril, Combo, Placebo
|
Ramipril, Tadalafil, Placebo, Combo
|
Combo, Placebo, Tadalafil, Ramipril
|
Placebo, Combo, Ramipril, Tadalafil
|
Tadalafil, Placebo, Ramipril, Combo
|
Ramipril, Combo, Tadalafil, Placebo
|
Combo, Ramipril, Placebo, Tadalafil
|
Placebo, Tadalafil, Combo, Ramipril
|
Tadalafil, Combo, Placebo, Ramipril
|
Ramipril, Placebo, Combo, Tadalafil
|
Combo, Tadalafil, Ramipril, Placebo
|
Placebo, Ramipril, Tadalafil, Combo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
First Treatment
STARTED
|
2
|
3
|
2
|
2
|
2
|
3
|
2
|
3
|
2
|
2
|
2
|
2
|
|
First Treatment
COMPLETED
|
2
|
2
|
2
|
1
|
2
|
3
|
2
|
2
|
2
|
2
|
1
|
1
|
|
First Treatment
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Washout
STARTED
|
2
|
1
|
2
|
1
|
1
|
2
|
2
|
2
|
1
|
2
|
1
|
1
|
|
Washout
COMPLETED
|
2
|
1
|
2
|
1
|
1
|
2
|
2
|
2
|
1
|
2
|
1
|
1
|
|
Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Treatment
STARTED
|
2
|
2
|
2
|
1
|
2
|
3
|
2
|
2
|
2
|
2
|
1
|
1
|
|
Second Treatment
COMPLETED
|
2
|
2
|
2
|
1
|
1
|
2
|
2
|
2
|
1
|
2
|
1
|
1
|
|
Second Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Third Treatment
STARTED
|
2
|
2
|
2
|
1
|
1
|
2
|
2
|
2
|
1
|
2
|
1
|
1
|
|
Third Treatment
COMPLETED
|
2
|
1
|
2
|
1
|
1
|
2
|
2
|
2
|
1
|
2
|
1
|
1
|
|
Third Treatment
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fourth Treatment
STARTED
|
2
|
1
|
2
|
1
|
1
|
2
|
2
|
2
|
1
|
2
|
1
|
1
|
|
Fourth Treatment
COMPLETED
|
2
|
1
|
2
|
1
|
1
|
2
|
2
|
2
|
1
|
2
|
1
|
1
|
|
Fourth Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tadalafil, Ramipril, Combo, Placebo
|
Ramipril, Tadalafil, Placebo, Combo
|
Combo, Placebo, Tadalafil, Ramipril
|
Placebo, Combo, Ramipril, Tadalafil
|
Tadalafil, Placebo, Ramipril, Combo
|
Ramipril, Combo, Tadalafil, Placebo
|
Combo, Ramipril, Placebo, Tadalafil
|
Placebo, Tadalafil, Combo, Ramipril
|
Tadalafil, Combo, Placebo, Ramipril
|
Ramipril, Placebo, Combo, Tadalafil
|
Combo, Tadalafil, Ramipril, Placebo
|
Placebo, Ramipril, Tadalafil, Combo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
First Treatment
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
First Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Second Treatment
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Second Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Treatment
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi and PE5i
Baseline characteristics by cohort
| Measure |
Completed Subjects
n=18 Participants
Subjects who completed all four treatment arms.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 hoursBeta cell function as measured during a frequently sampled IV glucose tolerance test
Outcome measures
| Measure |
Placeb Treatment
n=18 Participants
Measurements during placebo treatment for all 18 subjects who completed the protocol
|
Ramipril Treatment
n=18 Participants
Measurements during ramipril treatment for all 18 subjects who completed the protocol
|
Tadalafil Treatment
n=18 Participants
Measurements during tadalafil treatment for all 18 subjects who completed the protocol
|
Combination Treatment
n=18 Participants
Measurements during combination (ramipril and tadalafil) for all 18 subjects who completed the protocol
|
|---|---|---|---|---|
|
Beta Cell Function
|
241.2 microU/mM
Standard Error 45.2
|
232.3 microU/mM
Standard Error 38.1
|
292.1 microU/mM
Standard Error 38.9
|
287.6 microU/mM
Standard Error 54.3
|
PRIMARY outcome
Timeframe: three weeksPopulation: Those who completed protocol
As assessed using IV glucose tolerance test and calculated using Min Mod units mU/mm
Outcome measures
| Measure |
Placeb Treatment
n=18 Participants
Measurements during placebo treatment for all 18 subjects who completed the protocol
|
Ramipril Treatment
n=18 Participants
Measurements during ramipril treatment for all 18 subjects who completed the protocol
|
Tadalafil Treatment
n=18 Participants
Measurements during tadalafil treatment for all 18 subjects who completed the protocol
|
Combination Treatment
n=18 Participants
Measurements during combination (ramipril and tadalafil) for all 18 subjects who completed the protocol
|
|---|---|---|---|---|
|
Insulin Sensitivity
|
2.21 (mU/L)-1x(min)-1xL
Standard Error 0.35
|
1.76 (mU/L)-1x(min)-1xL
Standard Error 0.34
|
1.88 (mU/L)-1x(min)-1xL
Standard Error 0.25
|
1.76 (mU/L)-1x(min)-1xL
Standard Error 0.29
|
Adverse Events
Placebo Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ramipril Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Tadalafil Tretament
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combination Treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Treatment
n=23 participants at risk
Any adverse event that occurred during placebo treatment in anyone who received placebo treatment
|
Ramipril Treatment
n=24 participants at risk
Any adverse event that occured durng ramipril treatment in anyone who received ramipril treatment
|
Tadalafil Tretament
n=23 participants at risk
Any adverse event that occurred during tadalafil treatment in anyone who received tadalafil treatment
|
Combination Treatment
n=25 participants at risk
Any adverse event that occurred during combination (ramipril and tadalafil) treatment in anyone who received combination treatment
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
0.00%
0/23
|
8.3%
2/24 • Number of events 2
|
0.00%
0/23
|
8.0%
2/25 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place