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

May 7, 2013 updated by: Shenzhen Ausa Pharmed Co.,Ltd

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

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

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

756

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Anhui
      • Hefei, Anhui, China, 230022
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Anzhen Hospital,Capital Medical University
      • Beijing, Beijing, China, 100036
        • Recruiting
        • Peking University First Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Not yet recruiting
        • First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510030
        • Not yet recruiting
        • Guangdong General Hospital
    • Heilongjiang
      • Haibin, Heilongjiang, China, 150001
        • Not yet recruiting
        • First Affiliated Hospital of Harbin Medical University
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221006
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical College
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, China, 110002
        • Not yet recruiting
        • First Affiliated Hospital of China Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Zhongshan Hospital Fudan University
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Not yet recruiting
        • First Affiliated Hospital of the School of Medicine, Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China School of Medicine, West China Hospital ,Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Not yet recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.
5mg amlodipine combined with 0.4 mg of folic acid, daily.
Other Names:
  • 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.
amlodipine 5mg and folic acid 0.8mg daily
Other Names:
  • high dose
Active Comparator: amolodipine
5 mg amlodipine, once daily for 8 weeks.
amlodipine 5mg daily
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
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.
24-hour ambulatory blood pressure were examined at baseline and at 8 weeks of the trial in 96 participants.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

May 4, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

May 8, 2013

Last Update Submitted That Met QC Criteria

May 7, 2013

Last Verified

May 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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