Working… Menu
Trial record 1 of 1 for:    Felodipine Event Reduction
Previous Study | Return to List | Next Study

Felodipine Event Reduction Study (FEVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136863
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : June 25, 2010
Shanxi Kangbao Pharmaceutical company
Beijing Hypertension League Insititute
Information provided by:
Chinese Academy of Medical Sciences

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 Phase
Hypertension Drug: Felodipine Drug: Placebo Not Applicable

Layout table for study information
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
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Felodipine

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01136863

Layout table for location information
Fu Wai Hospital
Beijing, China, 100037
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Shanxi Kangbao Pharmaceutical company
Beijing Hypertension League Insititute
Layout table for investigator information
Principal Investigator: Lisheng Liu, MD Fu Wai Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lisheng Liu/professor, Fu Wai Hospital, CAMS & PUMC Identifier: NCT01136863    
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:
moderate to high risk patients
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents