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

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ClinicalTrials.gov Identifier: NCT01848873
Recruitment Status : Unknown
Verified May 2013 by Shenzhen Ausa Pharmed Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : May 8, 2013
Sponsor:
Collaborators:
Peking University First Hospital
Chinese PLA General Hospital
Capital Medical University
Fudan University
Ruijin Hospital
Nanchang University
First Affiliated Hospital of Fujian Medical University
First Affiliated Hospital of Harbin Medical University
China Medical University, China
Health Science Center of Xi'an Jiaotong University
Xuzhou Medical University
Anhui Medical University
Huazhong University of Science and Technology
West China Hospital
Guangdong Provincial People's Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Information provided by (Responsible Party):
Shenzhen Ausa Pharmed Co.,Ltd

Study Description
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Brief Summary:
To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and plasma homocystein.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Amlodipine Drug: amlodipine-FA tablet, low dose group Drug: amlodipine-FA tablet ,high dose group Phase 2 Phase 3

Detailed Description:

Traditional risk factors are estimated to account for only part of cardiovascular disease (CVD) risk. Non-traditional risk factors such as increased homocysteine concentration are believed to be causally related to CVD. The interactive effect between hypertension and hyperhomocysteinemia on the risk of CVD has received great attention. Methylenetetrahydrofolate reductase (MTHFR) was the main regulatory enzymes for homocysteine metabolism. MTHFR converts 5, 10-methylene-THF into 5-methyl-THF. Polymorphism of MTHFR C677T leads to a reduction in enzyme activity, which may lead to an increased concentration of plasma homocysteine and lower levels of serum folate, particularly in those with low folate intake. In the present study, we sought to assess: (1) the efficacy and safety of Amlodipine-folic Acid Tablets in lowering blood pressure and homocystein in patients with mild to moderate hypertension and hyperhomocysteinemia (hcy≥10μmol/L);(2) if the blood pressure and homocysteine-lowering efficacy of Amlodipine-folic Acid Tablets can be modified by individual methylenetetrahydrofolate reductase (MTHFR) C677T polymorphisms.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine in Patients With Mild to Moderate Hypertension and Hyperhomocysteinemia ：a Double-blind Randomized Controlled Trial
Study Start Date : January 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: amlodipine-FA tablet, low dose group
5mg amlodipine combined with 0.4 mg of folic acid (FA),once daily for 8 weeks.
 Drug: amlodipine-FA tablet, low dose group
5mg amlodipine combined with 0.4 mg of folic acid, daily.
Other Name: low dose
Experimental: amlodipine-FA tablet ,high dose group
5mg amlodipine combined with 0.8 mg of folic acid (FA), once daily for 8 weeks.
 Drug: amlodipine-FA tablet ,high dose group
amlodipine 5mg and folic acid 0.8mg daily
Other Name: high dose
Active Comparator: amolodipine
5 mg amlodipine, once daily for 8 weeks.
 Drug: Amlodipine
amlodipine 5mg daily
Other Name: control


Outcome Measures
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Primary Outcome Measures :
  1. Combined effective rate of blood pressure and plasma homocysteine reduction [ Time Frame: Blood pressure was examined at baseline and every 2 weeks for a total period of 8 weeks. Blood homocysteine concentrations were measured at baseline and at 4 and 8 weeks of the trial. ]

Secondary Outcome Measures :
  1. Blood pressure reduction or plasma homocysteine reduction [ Time Frame: Blood pressure was examined at baseline and every two weeks for a total period of 8 weeks. Blood homocysteine concentrations was examined at baseline and at 4 and 8 weeks of the trial. ]

Other Outcome Measures:
  1. 24-hour ambulatory blood pressure [ Time Frame: 24-hour ambulatory blood pressure were examined at baseline and at 8 weeks of the trial in 96 participants. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848873


Contacts
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Contact: Yong Huo, MD 86-10-66551122-2704 huoyong18@126.com
Contact: Yan Zhang, MD 86-10-66530556 drzhy1108@163.com

Locations
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China, Anhui
The First Affiliated Hospital of Anhui Medical University Not yet recruiting
Hefei, Anhui, China, 230022
China, Beijing
Anzhen Hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100029
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100036
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
China, Fujian
First Affiliated Hospital of Fujian Medical University Not yet recruiting
Fuzhou, Fujian, China, 350005
China, Guangdong
Guangdong General Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510030
China, Heilongjiang
First Affiliated Hospital of Harbin Medical University Not yet recruiting
Haibin, Heilongjiang, China, 150001
China, Hubei
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430022
China, Jiangsu
The Affiliated Hospital of Xuzhou Medical College Recruiting
Xuzhou, Jiangsu, China, 221006
China, Jiangxi
The Second Affiliated Hospital Of Nanchang University Not yet recruiting
Nanchang, Jiangxi, China, 330006
China, Liaoning
First Affiliated Hospital of China Medical University Not yet recruiting
Shenyang, Liaoning, China, 110002
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 200025
Zhongshan Hospital Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200032
China, Shanxi
First Affiliated Hospital of the School of Medicine, Xi'an Jiaotong University Not yet recruiting
Xi'an, Shanxi, China, 710061
China, Sichuan
West China School of Medicine, West China Hospital ,Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Sponsors and Collaborators
Shenzhen Ausa Pharmed Co.,Ltd
Peking University First Hospital
Chinese PLA General Hospital
Capital Medical University
Fudan University
Ruijin Hospital
Nanchang University
First Affiliated Hospital of Fujian Medical University
First Affiliated Hospital of Harbin Medical University
China Medical University, China
Health Science Center of Xi'an Jiaotong University
Xuzhou Medical University
Anhui Medical University
Huazhong University of Science and Technology
West China Hospital
Guangdong Provincial People's Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Yong Huo, MD Peking University First Hospital, Beijing, CHINA
More Information
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Layout table for additonal information
Responsible Party: Shenzhen Ausa Pharmed Co.,Ltd
ClinicalTrials.gov Identifier: NCT01848873    
Other Study ID Numbers: AUSA-amlodipine
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013
Keywords provided by Shenzhen Ausa Pharmed Co.,Ltd:
Hyperhomocysteinemia
Amlodipine-folic acid tablets
Hypertension
MTHFR C677T
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Hyperhomocysteinemia
Vascular Diseases
Cardiovascular Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
 Deficiency Diseases
Malnutrition
Nutrition Disorders
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents