Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine

• Status: Unknown status
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of Amlodipine-Folic Acid Tablets on reduction of blood pressure and plasma total homocysteine.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen Ausa Pharmed Co.,Ltd
• Collaborators: Ruijin Hospital; Second Affiliated Hospital of Nanchang University; Xuzhou Medical University
• Treatments: Amlodipine; Folic Acid; Vitamin B Complex

Criteria

Inclusion Criteria:

1. Aged 18-75 years;

2. Sedentary systolic blood pressure between 140 mmHg and 180 mmHg, and/or sedentary diastolic blood pressure between 90 mmHg and 110 mmHg;

3. Plasma homocysteine ≥ 10μmol/L;

4. ACEI-intolerance

5. Signed the written informed consent.

Exclusion Criteria:

1. Pregnant women or women within lactation period;

2. Hypersensitive to Calcium Channel Blocker (CCB) or folic acid;

3. Easily hypersensitiveness;

4. Diagnosed secondary hypertension or skeptical secondary hypertension;

5. Severe hypertension (sedentary systolic blood pressure greater than or equal to 180 mmHg and/or sedentary diastolic blood pressure greater than or equal to 110 mmHg)

6. Severe diseases:

1. 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, atrioventricular block above Ⅱlevel, et al;

2. 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) greater than 30 g/L;Stomach bulk resect and gastrojejunostomy;Stomach intestine malabsorption;

3. Urinary system:Serum creatinine greater than or equal to 200 mmol/L;Diagnosed stenosis of renal artery, solitary kidney;Renal transplantation;

4. 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;

5. Respiratory system:Pulmonary Heart Disease;Chronic Obstructive Pulmonary Disease(COPD);

6. Neuropsychiatric system:Transient Ischemia Attach (TIA) or stroke within 3 months;Severe peripheral nerve or vegetative nerve functional disturbance; Psyche or nervous system dysfunction;Drugs or alcohol dependence;

7. Others:Malignant tumor, malnutrition, haematogenesis dysfunction, et al;

7. Obviously abnormal laboratory examination or signs;

8. Taking other antihypertensive drugs and unwilling to stop;

9. Taking folic acid or other Vitamin B groups and unwilling to stop;

10. Ever to participant in any drug trial not yet approved within 4 weeks before the first visit.

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