| Trial ID: | L2022 |
| Source ID: | NCT01480791
|
| Associated Drug: |
Aliskiren Vs. Hydrochlorothiazide
|
| Title: |
Aliskiren vs Hydrochlorothiazide in Hypertensive Type II Diabetic Patients on Resistance Arteries
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Diabetes
|
| Interventions: |
DRUG: Aliskiren vs. hydrochlorothiazide|DRUG: Hydrochlorothiazide
|
| Outcome Measures: |
Primary: The primary endpoint is baseline-adjusted change in media/lumen ratio in patients who were randomized to aliskiren (group 1) comparatively to those randomized to hydrochlorothiazide (group 2), The primary endpoint is baseline-adjusted change in media/lumen ratio in patients who were randomized to aliskiren (group 1) comparatively to those randomized to hydrochlorothiazide (group 2), 6 months-1 year | Secondary: Secondary outcome: Pulse wave velocity (PWV) of aorta in hypertensive diabetic patients randomized to aliskiren versus those who were randomized to HCTZ., Pulse wave velocity (PWV) of aorta in hypertensive diabetic patients randomized to aliskiren versus those who were randomized to HCTZ., 6 months-1 year|Augmentation index (AI) of patients randomized to either aliskiren or hydrochlorothiazide, Evaluation by non invasive means with a SphygmoCor of augmentation index (AI) of central aortic blood pressure in response to either aliskiren or hydrochlorothiazide in hypertensive diabetic patients., 6 months-1 year|Flow-mediated dilation in hypertensive diabetic patients randomized to aliskiren vs. hydrochlorothiazide, Evaluation by non invasive means with ultrasound of flow-mediated dilation of the brachial artery in response to either aliskiren or hydrochlorothiazide in hypertensive diabetic patients., 6 months-1 year
|
| Sponsor/Collaborators: |
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital | Collaborators: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-01
|
| Completion Date: |
2013-12
|
| Results First Posted: |
|
| Last Update Posted: |
2015-05-19
|
| Locations: |
Cardiovascular Prevention Centre, Jewish General Hospital, Montreal, Quebec, H3T 1E2, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT01480791
|
