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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00523549 |
Purpose
The purpose of this study is to determine the effects of treatment with valsartan + amlodipine to a target systolic blood pressure (SBP)<130 mmHg compared to the Joint National Commission on the Treatment of Hypertension 7 recommended target SBP of <140 mmHg on the intrinsic diastolic properties of the myocardium in patients with hypertension and echocardiographic evidence of diastolic dysfunction.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Diastolic Dysfunction |
Drug: valsartan and amlodipine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Prospective, Randomized, Open-Label Study With Blinded Outcome Evaluation to Evaluate the Effects of Systolic Blood Pressure Lowering to Different Targets (Less Than 130 mmHg vs. Less Than 140 mmHg) on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction |
| Enrollment: | 193 |
| Study Start Date: | November 2006 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Treatment to target SBP of < 140 mmHg: Experimental |
Drug: valsartan and amlodipine
once a day
|
| Treatment to target SBP of < 130 mmHg: Experimental |
Drug: valsartan and amlodipine
once a day
|
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| United States, Florida | |
| Pensacola, Florida, United States, 32501 | |
| United States, New Jersey | |
| Sites in USA | |
| USA, New Jersey, United States | |
| United States, New York | |
| Flushing,, New York, United States, 11355 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CVAA489AUS01 |
| Study First Received: | August 30, 2007 |
| Last Updated: | December 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00523549 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hypertension systolic blood pressure diastolic dysfunction valsartan amlodipine |
|
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Vascular Diseases Calcium Channel Blockers Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Amlodipine Membrane Transport Modulators Therapeutic Uses Cardiovascular Diseases Valsartan Hypertension |