Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism - Full Text View

Sponsor:	Anhui Medical University
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

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Folic acid Enalapril Enalapril maleate Enalaprilat

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:

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)

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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 Province
Inistitute for Biomedicine, Anhui Medical University
Hefei, Anhui Province, 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

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

Keywords provided by Anhui Medical University:

enalapril
folic acid
hyperglycemia
hypertension
fasting plasma glucose

Additional relevant MeSH terms:

Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Hematinics
Growth Substances
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Protease Inhibitors
Folic Acid
Enalapril
Enalaprilat
Therapeutic Uses
Vitamins
Angiotensin-Converting Enzyme Inhibitors
Micronutrients

ClinicalTrials.gov processed this record on November 27, 2009