Felodipine Event Reduction Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01136863

Acronym

FEVER

Enrollment

9800

Registered

2010-06-04

Start date

1998-04-30

Completion date

2004-06-30

Last updated

2010-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, felodipine, moderate to high risk patients

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.

Interventions

DRUGFelodipine

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Composite of fatal and non-fatal stroke	During the study period

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026