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Felodipine Event Reduction Study (FEVER)

This study has been completed.
Sponsor:
Collaborators:
Shanxi Kangbao Pharmaceutical company
Beijing Hypertension League Insititute
Information provided by:
Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01136863
First received: June 2, 2010
Last updated: June 23, 2010
Last verified: January 2005
History of Changes
  Purpose

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
Hypertension
 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:

Drug Information available for: Felodipine
U.S. FDA Resources

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

  Eligibility

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

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

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

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

No publications provided by Chinese Academy of Medical Sciences

Additional 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:
hypertension
felodipine
moderate to high risk patients

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Felodipine
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013