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Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism

This study has been completed.
Sponsor:
Collaborators:
Peking University First Hospital
Fudan University
Harbin Medical University
China Medical University Hospital
Xi’an Jiaotong University College of Medicine
Nanjing Medical University
Information provided by:
Anhui Medical University
ClinicalTrials.gov Identifier:
NCT00520247
First received: August 17, 2007
Last updated: August 22, 2007
Last verified: August 2007
History of Changes
  Purpose

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 Intervention Phase
Plasma Total Homocysteine Level
Blood Pressure
 Drug: enalapril plus folic acid
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Anhui Medical University:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 443
Study Start Date: September 2005
Study Completion Date: February 2006
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)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   28 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520247

Locations
China, Anhui
Inistitute for Biomedicine, Anhui Medical University
Hefei, Anhui, China, 230032
Sponsors and Collaborators
Anhui Medical University
Peking University First Hospital
Fudan University
Harbin Medical University
China Medical University Hospital
Xi’an Jiaotong University College of Medicine
Nanjing Medical University
Investigators
Study Director: Ping Liu, Dr. Peking University First Hopital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00520247     History of Changes
Other Study ID Numbers: 2005L01101
Study First Received: August 17, 2007
Last Updated: August 22, 2007
Health Authority: China: Food and Drug Administration

Keywords provided by Anhui Medical University:
enalapril
folic acid
hyperglycemia
hypertension
fasting plasma glucose

Additional relevant MeSH terms:
Antihypertensive Agents
Enalapril
Enalaprilat
Folic Acid
Vitamin B Complex
Hematinics
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013