Felodipine Event Reduction Study
Information source: Chinese Academy of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Felodipine (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Chinese Academy of Medical Sciences Official(s) and/or principal investigator(s): Lisheng Liu, MD, Principal Investigator, Affiliation: Fu Wai Hospital
Summary
FEVER is an investigator-designed, prospective, multicentre,double-bind, randomized,
placebo-controlled,parallel-group trial. The primary objective is to compare the long-term
effects on the incidence of fatal and non-fatal stroke (and secondarily of other
cardiovascular events) of administering a small dose of the calcium antagonist felodipine (5
mg once a day) or of a placebo, in hypertensive patients whose blood pressure had
preliminarily been reduced by administering a low-dose diuretic (hydrochlorothiazide,12. 5 mg
once a day) to be continued in association with felodipine or placebo, throughout the trial.
Clinical Details
Official title: Felodipine Event Reduction Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Composite of fatal and non-fatal stroke
Secondary outcome: all cause deathcardiac event All cardiovascular events new onset diabetes
Eligibility
Minimum age: 50 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- SBP of 210 mmHg or less and DBP less than 115 mmHg if under antihypertensive
treatment; SBP 160-210 mmHg or DBP 95-115 mmHg if untreated. Presence of at least one
or two risk factors or cardiovascular diseases Informed consent obtained
Exclusion Criteria:
stroke or myocardial infarction during the previous 6 months; secondary hypertension;
unstable angina; cardiomyopathy or significant valvular disease; serum creatinine greater
than 178 mmol/l (2. 0 mg/dl); gout; uncontrolled diabetes(fasting plasma glucose > 10
mmol/l, 180 mg/dl despite therapy); serious pulmonary or hepatic disease; known
contraindications to study drugs; unwillingness to cooperate
Locations and Contacts
Fu Wai Hospital, Beijing 100037, China
Additional Information
Starting date: April 1998
Last updated: June 23, 2010
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