Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension
The objective of this study is to evaluate efficacy, safety and tolerability of the valsartan+amlodipine association in patients with mild to moderate essential hypertension, in comparison to amlodipine alone.
Patients should have mild to moderate essential hypertension [grades 1 and 2 of WHO classification (8)]. The diastolic blood pressure threshold for inclusion in this study is 95 mmHg, as these patients are more likely to benefit from association therapy than patients with lower diastolic blood pressure.
For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will not be included in this study. Moreover, patients developing severe hypertension (MSDBP > 110 mmHg and/or MSSBP > 180 mmHg) during the open-label treatment phase will be discontinued from the study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A National, Multicentric and Comparative Study to Evaluate Efficacy and Tolerability of the Association of Valsartan and Amlodipine Versus Amlodipine Alone in the Treatment of Essential Arterial Hypertension - Stages I and II (Mild to Moderate).|
- Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
- Change from baseline in the mean sitting systolic blood pressure from baseline after 8 weeks
- Adverse events after 8 weeks
- Change from baseline in standing blood pressure and heart rate after 8 weeks
|Study Start Date:||March 2004|
|Study Completion Date:||April 2005|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333489
|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|