Status:
COMPLETED
Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00367939
Start Date
December 1 2005
End Date
July 1 2006
Last Update
May 18 2017
Active Locations (1)
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1
Investigative Centers, Germany