Trial Outcomes & Findings for Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance (NCT NCT01252238)
NCT ID: NCT01252238
Last Updated: 2018-02-13
Results Overview
The difference (change) in HOMA calculated as Baseline HOMA minus 12-week HOMA value
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-02-13
Participant Flow
Recruitment occurred from 8/2009 thru 12/2011 at Brigham and Women's Hospital, Boston, MA.
All subjects washed out blood pressure medication for two weeks and ran in for two weeks on amlodipine 2.5-10mg titrated to BP \<160/90 every other day. All subjects consumed a very low salt calculated diet for one week followed by calculated high salt diet for 2 weeks prior to randomization
Participant milestones
| Measure |
Aliskiren
Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
|
Placebo Group
Only taking Amlodipine
Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.
|
Valsartan and Aliskiren
Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)
Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
4
|
Reasons for withdrawal
| Measure |
Aliskiren
Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
|
Placebo Group
Only taking Amlodipine
Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.
|
Valsartan and Aliskiren
Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)
Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren.
|
|---|---|---|---|
|
Overall Study
Sponsor terminated study
|
4
|
4
|
4
|
Baseline Characteristics
Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance
Baseline characteristics by cohort
| Measure |
Aliskiren
n=8 Participants
Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
|
Placebo Group
n=8 Participants
Only taking Amlodipine
Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.
|
Valsartan and Aliskiren
n=8 Participants
Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)
Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren.
|
Total
n=24 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 12 • n=5 Participants
|
51 years
STANDARD_DEVIATION 6 • n=7 Participants
|
47 years
STANDARD_DEVIATION 5 • n=5 Participants
|
48 years
STANDARD_DEVIATION 7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe difference (change) in HOMA calculated as Baseline HOMA minus 12-week HOMA value
Outcome measures
| Measure |
Aliskiren
n=4 Participants
Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
|
Placebo Group
n=4 Participants
Only taking Amlodipine
Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.
|
Valsartan and Aliskiren
n=4 Participants
Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)
Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren.
|
|---|---|---|---|
|
Change in Insulin Sensitivity by HOMA at 12 Weeks
|
-0.7 HOMA Scale
Standard Deviation 1.3
|
-0.4 HOMA Scale
Standard Deviation 1.4
|
-0.5 HOMA Scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Comparison of Baseline vs. study drug at 12 week2
Characteristic aortic imedeance, dynes x s/cm5
Outcome measures
| Measure |
Aliskiren
n=4 Participants
Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
|
Placebo Group
n=4 Participants
Only taking Amlodipine
Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.
|
Valsartan and Aliskiren
n=4 Participants
Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)
Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren.
|
|---|---|---|---|
|
Aortic Compliance
baseline
|
212 dyne x sec/cm5
Standard Error 88
|
241 dyne x sec/cm5
Standard Error 63
|
111 dyne x sec/cm5
Standard Error 7
|
|
Aortic Compliance
12 weeks
|
174 dyne x sec/cm5
Standard Error 57
|
127 dyne x sec/cm5
Standard Error 0.00000
|
519 dyne x sec/cm5
Standard Error 499
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Comparison of baseline vs at 12 weeks on study drug
Measure of pulsewave velocity cm/s
Outcome measures
| Measure |
Aliskiren
n=4 Participants
Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
|
Placebo Group
n=4 Participants
Only taking Amlodipine
Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.
|
Valsartan and Aliskiren
n=4 Participants
Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)
Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren.
|
|---|---|---|---|
|
Pulse Wave Velocity
baseline
|
991 cm/s
Standard Error 338
|
824 cm/s
Standard Error 106
|
1021 cm/s
Standard Error 5.6
|
|
Pulse Wave Velocity
12 weeks
|
824 cm/s
Standard Error 183
|
696 cm/s
Standard Error 0.000000
|
574 cm/s
Standard Error 584
|
Adverse Events
Aliskiren
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Valsartan and Aliskiren
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place