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).
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Novartis
- Enrollment
- 551
- Locations
- 1
- Primary Endpoint
- Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Severe hypertension (grade 3 of WHO classification: DBP \>= 110 mmHg and/or SBP ≥ 180 mmHg) or malignant hypertension.
- •Inability to completely discontinue all antihypertensive medications safely for a period of at least 2 weeks as required by the protocol.
- •Evidence of a secondary form of hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
Outcomes
Primary Outcomes
Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
Secondary Outcomes
- 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