UnknownPhase 2/3

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

China756 participantsStarted 2013-01

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Aged 18-75 years;
✓. Seated systolic blood pressure (SBP) between 140 mmHg and 180 mmHg and/or seated diastolic blood pressure between 90 mmHg and 110 mmHg;
✓. Plasma homocysteine ≥10umol/L；
✓. Signed the written informed consent.

Exclusion criteria

✕. Pregnant women or women within lactation period;
✕. Hypersensitive to calcium channel blocker (CCB) or folic acid;
✕. Easily hypersensitiveness
✕. Diagnosed secondum hypertension or skeptical secondum hypertension;
✕. Severe hypertension (sedentary systolic blood pressure≥180mmHg and/or sedentary diastolic blood pressure≥110mmHg)
✕. Severe diseases:
✕. Cardiovascular system:
✕. 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;

What they're measuring

Combined effective rate of blood pressure and plasma homocysteine reduction

Timeframe: 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.

Trial details

NCT IDNCT01848873

SponsorShenzhen Ausa Pharmed Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

Contact for this trial

Yong Huo, MD

86-10-66551122-2704 huoyong18@126.com

View on ClinicalTrials.gov More Essential Hypertension trials