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Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism

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.
 
ClinicalTrials.gov Identifier: NCT00520247
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : August 23, 2007
Sponsor:
Collaborators:
Peking University First Hospital
Huashan Hospital
Harbin Medical University
China Medical University Hospital
First Affiliated Hospital Xi'an Jiaotong University
Nanjing Medical University
Information provided by:
Anhui Medical University

Study Description
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Brief Summary:
Combinded therapy with folic acid and enalapril may significantly decrease plasma total homocysteine level and had beneficial effect on blood pressure reduction and glycometabolism.

Condition or disease Intervention/treatment Phase
Plasma Total Homocysteine Level Blood Pressure Drug: enalapril plus folic acid Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Antihypertensive and Plasma Total Homocysteine Lowering Combined Therapy With Enalapril and Folic Acid in Hypertensive Patients:A Multicenter Double Blind Randomized Clinical Trial
Study Start Date : September 2005
Actual Study Completion Date : February 2006

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Arms and Interventions
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Intervention Details:
  • Drug: enalapril plus folic acid
    enalapril 10.0 mg daily for 8 weeks (the control group); enalapril 10.0 mg plus folic acid 0.4 mg daily for 8 weeks (Low-dose group); enalapril 10.0 mg plus folic acid 0.8 mg daily for 8 weeks (High-dose group)

Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure of study participants was measured at baseline, 2th week, 4th week, 6th week and at the end of trial Subjects' plasma total homocysteine concentration were measured at baseline, 4th week and at 8th week. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Participants' living habit and life style were collected at baseline with the original questionnaires. A follow up questionnaire was sent out at 2th week, 4th week, 6th week and at the end of the trial. [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   28 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age≥18 years and less than 75 years
  • Essential hypertension patients
  • Sedentary systolic blood pressure≥140mmHg and less than 180mmHg, and/or sedentary diastolic blood pressure≥90mmHg and less than 110mmHg
  • Reproductive women agree to take a reliable contraception measure during the trial
  • Written informed consent

Exclusion Criteria:

  • Pregnant women
  • Women within lactateion period
  • Hypersensitive to angiotensin-converting enzyme inhibitor (ACEI) or folic acid
  • Easily hypersensitiveness
  • Diagnosed secondum hypertension or skeptical secondum hypertension
  • Severe hypertension (sedentary systolic blood pressure≥180mmHg and/or sedentary diastoleic blood pressure≥110mmHg)

Severe diseases:

  • Cardiovascular system:

    • Diagnosed cardia insufficiency (NYHAⅢ level and higher)
    • Hypertrophic obstructive cardiomyopathy (HOCM)
    • Clinical significantly valvular disease of the heart (VDH)
    • Acute coronary syndrome or coronary artery interventional therapy or coronary artery bypass graft within three months
    • Severe arrhythmia such as atrial flutter, atrial fibrillation, ventricular arrhythmia above Lown Ⅱ, atrioventricular block above Ⅱ level, et al

  • Alimentary system:

    • Active virus hepatitis
    • Any of alanine aminotransferase (ALT), aspartate aminotransferase (AST), galactosylhydroxylysyl glucosyltransferase (GGT), alkaline phosphatase (ALP), total bilirubin (TBIL), direct bilirubin (DB) was above 2 times of it's normal value upper limit, albumin (ALB)>30g/L
    • Stomach bulk resect and gastrojejunostomy, stomach intestine malabsorption

  • Urinary system:

    • Serum creatinine≥200mmol/L
    • Diagnosed stenosis of renal artery, solitary kidney
    • Renal transplantation

  • Endocrine system:

    • Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting glucose≥11.1mmol/L)
    • Diagnosed and uncontrolled hyperthyrosis

  • Respiratory system:

    • Chronic cough
    • Nervous or psyche system
    • Transient ischemia attach (TIA) or stoke within 3 months
    • Severe peripheral nerve or vegetative nerve functional disturbance
    • Psyche or nervous system dysfunction
    • Drugs or alcohol dependence

  • Others:

    • Malignant tumor, malnutrition, haematogenesis dysfunction, et al
    • Taking other antihypertensive drugs
    • Taking folic acid or other Vitamin B groups
Contacts and Locations
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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): NCT00520247


Locations
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China, Anhui
Inistitute for Biomedicine, Anhui Medical University
Hefei, Anhui, China, 230032
Sponsors and Collaborators
Anhui Medical University
Peking University First Hospital
Huashan Hospital
Harbin Medical University
China Medical University Hospital
First Affiliated Hospital Xi'an Jiaotong University
Nanjing Medical University
Investigators
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Study Director: Ping Liu, Dr. Peking University First Hopital
More Information
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ClinicalTrials.gov Identifier: NCT00520247    
Other Study ID Numbers: 2005L01101
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: August 23, 2007
Last Verified: August 2007
Keywords provided by Anhui Medical University:
enalapril
folic acid
hyperglycemia
hypertension
fasting plasma glucose
Additional relevant MeSH terms:
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Folic Acid
Enalapril
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
 Growth Substances
Physiological Effects of Drugs
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents