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临床试验/NCT00520247
NCT00520247已完成2 期

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

Anhui Medical University1 个研究点 分布在 1 个国家目标入组 443 人开始时间: 2005年9月最近更新:
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试验速览

阶段
2 期
状态
已完成
发起方
入组人数
443
试验地点
1
主要终点
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.

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
28 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Malignant tumor, malnutrition, haematogenesis dysfunction, et al
  • Taking other antihypertensive drugs
  • Taking folic acid or other Vitamin B groups

结局指标

主要结局

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.

时间窗: 8 weeks

次要结局

  • 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.(8 weeks)

研究者

发起方
Anhui Medical University
申办方类型
Other

研究点 (1)

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