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

Last updated: May 7, 2013
Sponsor: Shenzhen Ausa Pharmed Co.,Ltd
Overall Status: Trial Status Unknown

Phase

2/3

Condition

High Blood Pressure (Hypertension - Pediatric)

Williams Syndrome

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT01848873
AUSA-amlodipine
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18-75 years;

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

  3. Plasma homocysteine ≥10umol/L；

  4. Signed the written informed consent.

Exclusion

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 sedentarydiastolic blood pressure≥110mmHg)

  6. Severe diseases:

  7. Cardiovascular system:

  8. Diagnosed cardia insufficiency (NYHAⅢ level and higher); Hypertrophic obstructivecardiomyopathy (HOCM);Clinical significantly valvular disease of the heart (VDH);Acute coronary syndrome or coronary artery interventional therapy orcoronary artery bypass graft within three months; Severe arrhythmia such asatrial flutter, atrial fibrillation, atrioventricular block above Ⅱ level, et al;

  9. Alimentary system:

  10. Active virus hepatitis; Any of alanine aminotransferase (ALT), aspartateaminotransferase (AST), galactosylhydroxylysyl glucosyltransferase (GGT),alkaline phosphatase (ALP), total bilirubin (TBIL), direct bilirubin (DB) wasabove 2 times of it's normal value upper limit, albumin (ALB) ≤30g/L;Stomach bulkresect and gastrojejunostomy, stomach intestine malabsorption;

  11. Urinary system:

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

  13. Endocrine system:

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

  15. Respiratory system:

  16. Pulmonary heart disease , chronic obstructive lung disease;

  17. Nervous or psyche system:

  18. Transient ischemia attach (TIA) or stoke within 3 months; Severe peripheral nerveor vegetative nerve functional disturbance; Psyche or nervous systemdysfunction;Drugs or alcohol dependence.

  19. Others:

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

  21. Obvious signs or abnormal laboratory examination;

  22. Taking other antihypertensive drugs and unwilling to stop;

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

Study Design

Total Participants: 756
Study Start date:
January 01, 2013
Estimated Completion Date:
August 31, 2013

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Site Not Available

  • Anzhen Hospital,Capital Medical University

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing 100036
    China

    Active - Recruiting

  • First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, Guangdong 510030
    China

    Site Not Available

  • First Affiliated Hospital of Harbin Medical University

    Haibin, Heilongjiang 150001
    China

    Site Not Available

  • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu 221006
    China

    Active - Recruiting

  • The Second Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • First Affiliated Hospital of China Medical University

    Shenyang, Liaoning 110002
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • First Affiliated Hospital of the School of Medicine, Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • West China School of Medicine, West China Hospital ,Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

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