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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


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 death

cardiac event

All cardiovascular events

new onset diabetes


Minimum age: 50 Years. Maximum age: 79 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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