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

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and plasma homocystein.

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

Details

• Lead Sponsor: Shenzhen Ausa Pharmed Co.,Ltd
• Collaborators: Anhui Medical University; Capital Medical University; China Medical University, China; Chinese PLA General Hospital; First Affiliated Hospital of Fujian Medical University; First Affiliated Hospital of Harbin Medical University; Fudan University; Guangdong General Hospital; Guangdong Provincial People's Hospital; Health Science Center of Xi'an Jiaotong University; Health Science Center of Xi’an Jiaotong University; Huazhong University of Science and Technology; Nanchang University; Peking University First Hospital; Ruijin Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; West China Hospital; Xuzhou Medical University
• Treatments: Amlodipine; Folic Acid; Vitamin B Complex

Criteria

Inclusion Criteria:

1. Aged 18-75 years;

2. Seated systolic blood pressure (SBP) between 140 mmHg and 180 mmHg and/or seated diastolic blood pressure between 90 mmHg and 110 mmHg;

3. Plasma homocysteine ≥10umol/L；

4. 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 secondum hypertension or skeptical secondum hypertension;

5. Severe hypertension (sedentary systolic blood pressure≥180mmHg and/or sedentary diastolic blood pressure≥110mmHg)

6. Severe diseases:

1. Cardiovascular system:

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

3. Alimentary system:

4. 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;

5. Urinary system:

6. Serum creatinine≥200μmol/L ; Diagnosed stenosis of renal artery, solitary kidney, renal transplantation;

7. Endocrine system:

8. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting glucose≥11.1mmol/L); Diagnosed and uncontrolled hyperthyrosis;

9. Respiratory system:

10. Pulmonary heart disease , chronic obstructive lung disease;

11. Nervous or psyche system:

12. 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.

13. Others:

14. Malignant tumor, malnutrition, haematogenesis dysfunction, et al;

7. Obvious signs or abnormal laboratory examination;

8. Taking other antihypertensive drugs and unwilling to stop;

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