Felodipine Event Reduction Study

Chinese Academy of Medical Sciences9,800 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

9,800

Conditions

Hypertension

Interventions

FelodipineDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 79 Years

Medical Language ↔ Plain English

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 (1)

Fu Wai Hospital

Beijing, China

Outcomes

Primary Outcomes

Composite of fatal and non-fatal stroke

Time frame: During the study period

Secondary Outcomes

all cause death

Time frame: during the study period

cardiac event

Time frame: during the study period

All cardiovascular events

Time frame: during the study period

new onset diabetes

Time frame: during the study period

Data from ClinicalTrials.gov

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