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Completed

NCT Number: NCT01136863

Felodipine Event Reduction Study

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Wai Hospital

Beijing, 100037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Felodipine

Drug

Placebo

Drug

Primary outcomes

  1. Composite of fatal and non-fatal stroke

    Time frame: During the study period

Secondary outcomes

  1. all cause death

    Time frame: during the study period

  2. cardiac event

    Time frame: during the study period

  3. All cardiovascular events

    Time frame: during the study period

  4. new onset diabetes

    Time frame: during the study period

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Collaborators

  • Beijing Hypertension League Insititute
  • Shanxi Kangbao Pharmaceutical company

Registry information

Acronym: FEVER

Important dates

Study start
1998
Primary completion
2004
Study completion
2004
First posted
Jun 4, 2010
Registry last updated
Jun 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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