Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00333489
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Status Verified: 2006-06
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-05
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 551

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in the mean sitting diastolic blood pressure after 8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland