Felodipine Event Reduction Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 9,800
- Locations
- 1
- Primary Endpoint
- Composite of fatal and non-fatal stroke
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
felodipine group, active, pill
felodipine and HCTZ treatment group
Intervention: Felodipine (Drug)
placebo, no treatment, pill
placebo and HCTZ group
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Composite of fatal and non-fatal stroke
Time Frame: During the study period
Secondary Outcomes
- all cause death(during the study period)
- cardiac event(during the study period)
- All cardiovascular events(during the study period)
- new onset diabetes(during the study period)