Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension
|ClinicalTrials.gov Identifier: NCT00333489|
Recruitment Status : Completed
First Posted : June 5, 2006
Last Update Posted : November 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: valsartan||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||551 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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).|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||April 2005|
|Actual Study Completion Date :||April 2005|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333489
|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|