Felodipine Event Reduction Study

NCT01136863 | Completed DMC

• 1 other identifier: 96-906-02-11
• Study Type: interventional
• Target: 9,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

hypertension; felodipine; moderate to high risk patients

Outcome Measures

Primary Outcomes (1)

• Composite of fatal and non-fatal stroke

  During the study period

Secondary Outcomes (4)

• all cause death

  during the study period

• cardiac event

  during the study period

• All cardiovascular events

  during the study period

• new onset diabetes

  during the study period

Study Arms (2)

felodipine group, active, pill

ACTIVE COMPARATOR

felodipine and HCTZ treatment group

Drug: Felodipine

placebo, no treatment, pill

PLACEBO COMPARATOR

placebo and HCTZ group

Drug: Placebo

Interventions

Felodipine DRUG

felodipine group, active, pill

Placebo DRUG

placebo, no treatment, pill

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Shanxi Kangbao Pharmaceutical company: collaborator
• Beijing Hypertension League Insititute: collaborator

Study Sites (1)

Fu Wai Hospital

Beijing, 100037, China

Location

Related Publications (1)

• Zhang Y, Zhang X, Liu L, Zanchetti A; FEVER Study Group. Is a systolic blood pressure target <140 mmHg indicated in all hypertensives? Subgroup analyses of findings from the randomized FEVER trial. Eur Heart J. 2011 Jun;32(12):1500-8. doi: 10.1093/eurheartj/ehr039. Epub 2011 Feb 22.

  PMID: 21345850 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Felodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lisheng Liu, MD

  Fu Wai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 4, 2010
• Study Start: April 1, 1998
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: June 25, 2010

Record last verified: 2005-01

Locations

CN (1)