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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 + amlodipine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | 229 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Standard treatment regimen
(Valsartan + Amlodipine to target SBP of < 140 mmHg)
|
Drug: valsartan + amlodipine
(to target SBP of < 140 mmHg) once a day
|
|
Experimental: Intensive treatment regimen
(Valsartan + Amlodipine to target SBP < 130 mm Hg)
|
Drug: valsartan + amlodipine
(to target SBP < 130 mm Hg) 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
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00523549 History of Changes |
| Other Study ID Numbers: | CVAA489AUS01 |
| Study First Received: | August 30, 2007 |
| Results First Received: | December 6, 2010 |
| Last Updated: | February 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Hypertension systolic blood pressure diastolic dysfunction valsartan amlodipine |
|
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |