Felodipine Event Reduction Study (FEVER)

This study has been completed.
Shanxi Kangbao Pharmaceutical company
Beijing Hypertension League Insititute
Information provided by:
Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
First received: June 2, 2010
Last updated: June 23, 2010
Last verified: January 2005
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.

Condition Intervention
Drug: Felodipine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Felodipine Event Reduction Study

Resource links provided by NLM:

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Composite of fatal and non-fatal stroke [ Time Frame: During the study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • all cause death [ Time Frame: during the study period ] [ Designated as safety issue: No ]
  • cardiac event [ Time Frame: during the study period ] [ Designated as safety issue: No ]
  • All cardiovascular events [ Time Frame: during the study period ] [ Designated as safety issue: No ]
  • new onset diabetes [ Time Frame: during the study period ] [ Designated as safety issue: No ]

Enrollment: 9800
Study Start Date: April 1998
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: felodipine group, active, pill
felodipine and HCTZ treatment group
Drug: Felodipine
Placebo Comparator: placebo, no treatment, pill
placebo and HCTZ group
Drug: Placebo


Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01136863

Fu Wai Hospital
Beijing, China, 100037
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Shanxi Kangbao Pharmaceutical company
Beijing Hypertension League Insititute
Principal Investigator: Lisheng Liu, MD Fu Wai Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisheng Liu/professor, Fu Wai Hospital, CAMS & PUMC
ClinicalTrials.gov Identifier: NCT01136863     History of Changes
Other Study ID Numbers: 96-906-02-11 
Study First Received: June 2, 2010
Last Updated: June 23, 2010
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences:
moderate to high risk patients

Additional relevant MeSH terms:
Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 24, 2016