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. 2017 Aug 17;2017(8):CD006612. doi: 10.1002/14651858.CD006612.pub5

NCT01956786.

Study name Efficacy of amlodipine‐folic acid tablets on reduction of blood pressure and plasma homocysteine
Methods

  1. Allocation: randomised.

  2. Endpoint classification: safety/efficacy study.

  3. Intervention model: parallel assignment.

  4. Masking: double‐blind (participant, caregiver, investigator, outcomes assessor).

  5. Primary purpose: treatment.

  6. Study phase:

    1. Phase 2

    2. Phase 3
Participants Age: 18 years to 75 years.
Gender: both.
Inclusion criteria:

  1. Aged 18‐75 years.

  2. Sedentary systolic blood pressure between 140 mmHg and 180 mmHg, and/or sedentary diastolic blood pressure between 90 mmHg and 110 mmHg.

  3. Plasma homocysteine ≥ 10 μmol/L.

  4. Angiotension‐converting enzyme inhibitor Intolerance.

  5. Signed the written informed consent.


Exclusion criteria:

  1. Pregnant women or women within lactation period.

  2. Hypersensitive to calcium channel blocker or folic acid.

  3. Easily hypersensitiveness;

  4. Diagnosed secondary hypertension or sceptical secondary hypertension.

  5. Severe hypertension (sedentary systolic blood pressure greater than or equal to 180 mmHg and/or sedentary diastolic blood pressure greater than or equal to 110 mmHg).

  6. Severe diseases: cardiovascular system, alimentary system, urinary system, endocrine system, respiratory system, neuropsychiatric system, and others such as malignant tumour, malnutrition, hematogenesis dysfunction.

  7. Obviously abnormal laboratory examination or signs.

  8. Taking other antihypertensive drugs and unwilling to stop.

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

  10. Participation in any drug trial not yet approved within 4 weeks before the first visit.
Interventions

  1. Experimental (low‐dose group): amlodipine‐folic acid tablet: 5 mg amlodipine combined with 0.4 mg folic acid, once daily.

  2. Experimental (high‐dose group): amlodipine‐folic acid tablet: 5 mg amlodipine combined with 0.8 mg folic acid,once daily.

  3. Control: amlodipine: 5 mg, once daily.
Outcomes

  1. Primary: combined effective rate of blood pressure and plasma homocysteine reduction.

  2. Secondary:

    1. Blood pressure reduction

    2. Plasma homocysteine reduction
Starting date September 2013.
Contact information Wang Jiguang, MD. Ruijin Hospital, Shanghai Jiao Tong University.
Notes

  1. Official title: efficacy of amlodipine‐folic acid tablets on reduction of blood pressure and plasma homocysteine in patients with mild to moderate hypertension, hyperhomocysteinaemia and angiotension‐converting enzyme inhibitor Intolerance.

  2. Sponsor: Shenzhen Ausa Pharmed Co.,Ltd.

  3. Collaborators:

    1. Ruijin Hospital

    2. Second Affiliated Hospital of Nanchang University

    3. Xuzhou Medical College

  1. Information provided by (Responsible party):

    1. Shenzhen Ausa Pharmed Co.,Ltd

  1. Estimated enrolled: 540.

  2. Listed location countries: China.