Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism

August 22, 2007 updated by: Anhui Medical University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant women
  2. Women within lactateion period
  3. Hypersensitive to Angiotensin-Converting Enzyme Inhibitor (ACEI) or folic acid
  4. Easily hypersensitiveness
  5. Diagnosed secondum hypertension or skeptical secondum hypertension
  6. Severe hypertension (sedentary systolic blood pressure greater than or equal to 180 mmHg and/or sedentary diastoleic blood pressure greater than or equal to 110 mmHg)

  7. Severe diseases:

    • Cardiovascular system
    • Diagnosed cardia insufficiency (New York Health Association [NYHA] III 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 ?, atrioventricular block above II level, etc.
    • Alimentary system disorders
    • 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) greater than 30 g/L
    • Stomach bulk resect and gastrojejunostomy, stomach intestine malabsorption

    Urinary system:

    • Serum creatinine greater than or equal to 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 greater than or equal to 11.1 mmol/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, etc.
  8. Taking other antihypertensive drugs
  9. Taking folic acid or other Vitamin B groups

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
  2. Subjects' plasma total homocysteine concentration were measured at baseline, 4th week and at 8th week.

Secondary Outcome Measures:

  1. Participants' living habit and life style were collected at baseline with the original questionnaires.
  2. A follow up questionnaire was sent out at 2th week, 4th week, 6th week and at the end of the trial.

Study Type

Interventional

Enrollment (Actual)

443

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230032
        • Inistitute for Biomedicine, Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Medical University

Collaborators

Peking University First Hospital
China Medical University Hospital
Huashan Hospital
First Affiliated Hospital Xi'an Jiaotong University
Nanjing Medical University
Harbin Medical University

Investigators

  • Study Director: Ping Liu, Dr., Peking University First Hopital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (ACTUAL)

February 1, 2006

Study Registration Dates

First Submitted

August 17, 2007

First Submitted That Met QC Criteria

August 22, 2007

First Posted (ESTIMATE)

August 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2007

Last Update Submitted That Met QC Criteria

August 22, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005L01101

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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