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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00939588 |
Purpose
This study is designed as a mechanistic study to compare the effect of two different combinations of anti-hypertensive treatments (aliskiren and valsartan vs. telmisartan and ramipril) on the renin-angiotensin-aldosterone system (RAAS) in patients with moderate hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Aliskiren/ Valsartan Drug: Telmisartan/ Ramipril |
Phase II |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment |
| Official Title: | An 8 Week, Double-blind, Randomized, Parallel-group Study to Compare the Effect of Aliskiren 300mg + Valsartan 320mg vs. Telmisartan 80mg + Ramipril 10mg on Biomarkers of the Renin-angiotensin-aldosterone System in Moderate Hypertension |
| Estimated Enrollment: | 110 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Aliskiren and Valsartan: Experimental | Drug: Aliskiren/ Valsartan |
| Telmisartan and Ramipril: Active Comparator | Drug: Telmisartan/ Ramipril |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
More Information
| Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CSPV100A2225 |
| Study First Received: | July 9, 2009 |
| Last Updated: | July 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00939588 History of Changes |
| Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation |
|
Aliskiren, hypertension, renin-angiotensin-aldosterone system |
|
Molecular Mechanisms of Pharmacological Action Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Ramipril Pharmacologic Actions Protease Inhibitors |
Angiotensin II Type 1 Receptor Blockers Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Valsartan Hypertension |