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Felodipine Event Reduction Study (FEVER)

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ClinicalTrials.gov Identifier: NCT01136863
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : June 25, 2010
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Hypertension Drug: Felodipine Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Felodipine Event Reduction Study
Study Start Date : April 1998
Primary Completion Date : June 2004
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Felodipine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Composite of fatal and non-fatal stroke [ Time Frame: During the study period ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: June 25, 2010
Last Verified: January 2005

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
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents