Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00809926 |
Evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.
Condition | Intervention | Phase |
---|---|---|
Stage 2 Hypertension |
Drug: Valsartan/aliskiren Drug: Valsartan |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An 8-Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Efficacy and Safety of Valsartan Administered in Combination With Aliskiren (160/150 mg, 320/300 mg) Versus Valsartan Alone (160 mg, 320 mg) in Patients With Stage 2 Hypertension |
Estimated Enrollment: | 762 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Valsartan/aliskiren (160/150mg) for 2 weeks Valsartan/aliskiren (320/300mg) for another 6 weeks
|
Drug: Valsartan/aliskiren
Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg)
|
2: Active Comparator
Valsartan (160mg) 2 weeks - Valsartan (320mg) 6 weeks
|
Drug: Valsartan
Valsartan (160mg 2weeks- Valsartan (320mg) 6 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSPV100AUS01 |
Study First Received: | December 16, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00809926 |
Health Authority: | United States: Food and Drug Administration |
Hypertension, aliskiren and valsartan |
Vascular Diseases Valsartan Hypertension |
Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |