Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: valsartan + amlodipine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharma Ag, Study Director, Affiliation: Novartis
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
Clinical Details
Official title: An Multicenter Study to Evaluate the Efficacy and Safety of a 5 Week Therapy With the Combination of Valsartan 160 mg Plus Amlodipine 10 mg in Hypertensive Patients Not Adequately Responding to a 5 Week Therapy With Ramipril 5 mg and Felodipine 5 mg
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To investigate whether 5 weeks of treatment with valsartan 160mg + amlodipine 10mg provide add'l mean sitting systolic BP reduction in patients not adequately responding to 5 weeks of treatment with ramipril + felodipine--i.e., mean systolic BP
Secondary outcome: To evaluate the effects of valsartan 160 mg plus amlodipine 10 mg on mean sitting diastolic BP, normalization and responder rate.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Investigative Centers, Germany
Additional Information
Starting date: December 2005
Last updated: November 13, 2006
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