- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01136863
Felodipine Event Reduction Study (FEVER)
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beijing, China, 100037
- Fu Wai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: felodipine group, active, pill
felodipine and HCTZ treatment group
|
|
Placebo Comparator: placebo, no treatment, pill
placebo and HCTZ group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of fatal and non-fatal stroke
Time Frame: During the study period
|
During the study period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all cause death
Time Frame: during the study period
|
during the study period
|
cardiac event
Time Frame: during the study period
|
during the study period
|
All cardiovascular events
Time Frame: during the study period
|
during the study period
|
new onset diabetes
Time Frame: during the study period
|
during the study period
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lisheng Liu, MD, Fu Wai Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Felodipine
Other Study ID Numbers
- 96-906-02-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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