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Trial record 73 of 99 for:    AMLODIPINE AND VALSARTAN

Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance

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ClinicalTrials.gov Identifier: NCT01252238
Recruitment Status : Terminated (Study sponsor terminated study due to AE's reported with valsartan and aliskiren)
First Posted : December 2, 2010
Results First Posted : September 5, 2013
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Insulin Sensitivity
Aortic Compliance
Diastolic Function
Interventions Drug: Aliskiren
Drug: Valsartan and Aliskiren
Drug: Amlodipine
Enrollment 24
Recruitment Details Recruitment occurred from 8/2009 thru 12/2011 at Brigham and Women's Hospital, Boston, MA.
Pre-assignment Details 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
Arm/Group Title Aliskiren Placebo Group Valsartan and Aliskiren
Hide Arm/Group Description Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.

Only taking Amlodipine

Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.

Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)

Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren.

Period Title: Overall Study
Started 8 8 8
Completed 4 [1] 4 [1] 4 [1]
Not Completed 4 4 4
Reason Not Completed
Sponsor terminated study             4             4             4
[1]
sponsor terminated study
Arm/Group Title Aliskiren Placebo Group Valsartan and Aliskiren Total
Hide Arm/Group Description Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.

Only taking Amlodipine

Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.

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 of all reporting groups
Overall Number of Baseline Participants 8 8 8 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  87.5%
7
  87.5%
8
 100.0%
22
  91.7%
>=65 years
1
  12.5%
1
  12.5%
0
   0.0%
2
   8.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 24 participants
47  (12) 51  (6) 47  (5) 48  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
Female
4
  50.0%
6
  75.0%
2
  25.0%
12
  50.0%
Male
4
  50.0%
2
  25.0%
6
  75.0%
12
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 8 participants 24 participants
8 8 8 24
1.Primary Outcome
Title Change in Insulin Sensitivity by HOMA at 12 Weeks
Hide Description The difference (change) in HOMA calculated as Baseline HOMA minus 12-week HOMA value
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aliskiren Placebo Group Valsartan and Aliskiren
Hide Arm/Group Description:
Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.

Only taking Amlodipine

Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.

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 Number of Participants Analyzed 4 4 4
Mean (Standard Deviation)
Unit of Measure: HOMA Scale
-0.7  (1.3) -0.4  (1.4) -0.5  (1.5)
2.Secondary Outcome
Title Aortic Compliance
Hide Description Characteristic aortic imedeance, dynes x s/cm5
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Comparison of Baseline vs. study drug at 12 week2
Arm/Group Title Valsartan and Aliskiren Aliskiren Placebo Group
Hide Arm/Group Description:

Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)

Valsartan and Aliskiren: Subject taking combination of valsartan and aliskiren.

Aliskiren: Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.

Only taking Amlodipine

Amlodipine: Taking Amlodipine as prescribed by MD for management of high blood pressure.

Overall Number of Participants Analyzed 4 4 4
Mean (Standard Error)
Unit of Measure: dyne x sec/cm5
baseline 212  (88) 241  (63) 111  (7)
12 weeks 174  (57) 127  (0.00000) 519  (499)
3.Other Pre-specified Outcome
Title Pulse Wave Velocity
Hide Description Measure of pulsewave velocity cm/s
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Comparison of baseline vs at 12 weeks on study drug
Arm/Group Title Valsartan and Aliskiren Aliskiren Placebo Group
Hide Arm/Group Description:

Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)

Valsartan and Aliskiren: Subject taking combination of valsartan and aliskiren.

Aliskiren: Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.

Only taking Amlodipine

Amlodipine: Taking Amlodipine as prescribed by MD for management of high blood pressure.

Overall Number of Participants Analyzed 4 4 4
Mean (Standard Error)
Unit of Measure: cm/s
baseline 991  (338) 824  (106) 1021  (5.6)
12 weeks 824  (183) 696  (0.000000) 574  (584)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aliskiren Placebo Group Valsartan and Aliskiren
Hide Arm/Group Description Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.

Only taking Amlodipine

Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.

Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)

Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren.

All-Cause Mortality
Aliskiren Placebo Group Valsartan and Aliskiren
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aliskiren Placebo Group Valsartan and Aliskiren
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aliskiren Placebo Group Valsartan and Aliskiren
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
No conclusions can be drawn from study due to very low sample size. The sponsor terminated the study after a separate study reported adverse events in a diabetic population who had taken both valsartan and aliskiren.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jonathan Williams
Organization: Brigham and Women's Hospital
Phone: 617-278-0882
EMail: jwilliams5@partners.org
Layout table for additonal information
Responsible Party: Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01252238     History of Changes
Other Study ID Numbers: 2010p001286
First Submitted: December 1, 2010
First Posted: December 2, 2010
Results First Submitted: June 24, 2013
Results First Posted: September 5, 2013
Last Update Posted: February 13, 2018