Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
NCT ID: NCT01848873
Last Updated: 2013-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
756 participants
INTERVENTIONAL
2013-01-31
2013-08-31
Brief Summary
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Detailed Description
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In all, about 756 patients with mild or moderate hypertension and hyperhomocysteinemia will be recruited from about 18 hospitals in different Chinese regions. All hospitals are certified as clinical pharmacology centers by the State Food and Drug Administration (SFDA) in China. Eligible subjects are randomly and double-blindly assigned to one of the three treatment groups: 1) amlodipine tablet (5 mg, control group); 2) amlodipine-folic acid tablet (5mg amlodipine combined with 0.4 mg of folic acid, low FA group); or 3) amlodipine-folic acid tablet (5 mg amlodipine combined with 0.8 mg of folic acid, high FA group), once daily for 8 weeks.
The allocation of participants was programmed by an independent statistical coordinating center, encrypted, and sent to each study center. Tablet containers were labeled only with the name of the trial and the allocated concealment number. The participants, care partners, and all staff directly involved in the trial were blinded to interventions during the period of the trial.
Demographic and clinical information were obtained at baseline. Blood pressure was examined at baseline and every two weeks for a total period of 8 weeks. Blood homocysteine and folate concentrations were examined at baseline and at 4 and 8 weeks of the trial. MTHFR C677T genotypes were determined for each study subject.
All analyses will be performed according to the principle of intention to treat.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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amlodipine-FA tablet, low dose group
5mg amlodipine combined with 0.4 mg of folic acid (FA),once daily for 8 weeks.
amlodipine-FA tablet, low dose group
5mg amlodipine combined with 0.4 mg of folic acid, daily.
amlodipine-FA tablet ,high dose group
5mg amlodipine combined with 0.8 mg of folic acid (FA), once daily for 8 weeks.
amlodipine-FA tablet ,high dose group
amlodipine 5mg and folic acid 0.8mg daily
amolodipine
5 mg amlodipine, once daily for 8 weeks.
Amlodipine
amlodipine 5mg daily
Interventions
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Amlodipine
amlodipine 5mg daily
amlodipine-FA tablet, low dose group
5mg amlodipine combined with 0.4 mg of folic acid, daily.
amlodipine-FA tablet ,high dose group
amlodipine 5mg and folic acid 0.8mg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Chinese PLA General Hospital
OTHER
Capital Medical University
OTHER
Fudan University
OTHER
Ruijin Hospital
OTHER
Nanchang University
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
China Medical University, China
OTHER
Xi'an Jiaotong University
OTHER
Xuzhou Medical University
OTHER
Anhui Medical University
OTHER
Huazhong University of Science and Technology
OTHER
West China Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Shenzhen Ausa Pharmed Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Yong Huo, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital, Beijing, CHINA
Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
First Affiliated Hospital of Harbin Medical University
Haibin, Heilongjiang, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of the School of Medicine, Xi'an Jiaotong University
Xi’an, Shanxi, China
West China School of Medicine, West China Hospital ,Sichuan University
Chengdu, Sichuan, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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AUSA-amlodipine
Identifier Type: -
Identifier Source: org_study_id
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