Felodipine Event Reduction Study

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Drug: Placebo; Drug: Felodipine

• Registration Number: NCT01136863
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-04
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Status Verified: 2005-01
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Last Update Submitted: 2010-06-23
• Last Update Posted: 2010-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo, no treatment, pill	Placebo	placebo and HCTZ group
felodipine group, active, pill	Felodipine	felodipine and HCTZ treatment group

Primary Outcome Measures

Name	Time	Method
Composite of fatal and non-fatal stroke	During the study period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fu Wai Hospital; 🇨🇳 Beijing, China