Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with ACE inhibitor plus calcium channel blocker

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Amlodipine; Felodipine; Ramipril; Valsartan

Criteria

Inclusion Criteria:

• Male or female patients (18 years or older)

• Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).

• Patients with moderate essential hypertension (WHO II)

Exclusion Criteria:

• Severe hypertension

• Pregnant or nursing women

• Treated hypertensive patients with controlled hypertension under current therapy (MSDBP < 90 mmHg and MSSBP < 140 mmHg)

• A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

• Other protocol-defined exclusion criteria may apply