Status:
UNKNOWN
Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
Lead Sponsor:
Shenzhen Ausa Pharmed Co.,Ltd
Collaborating Sponsors:
Peking University First Hospital
Chinese PLA General Hospital
Conditions:
Essential Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and plasma homocystein.
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 causa...
Eligibility Criteria
Inclusion
- 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
- 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;
- Alimentary system:
- 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;
- Urinary system:
- Serum creatinine≥200μmol/L ; Diagnosed stenosis of renal artery, solitary kidney, renal transplantation;
- Endocrine system:
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting glucose≥11.1mmol/L); Diagnosed and uncontrolled hyperthyrosis;
- Respiratory system:
- Pulmonary heart disease , chronic obstructive lung disease;
- Nervous or psyche system:
- 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.
- Others:
- Malignant tumor, malnutrition, haematogenesis dysfunction, et al;
- Obvious signs or abnormal laboratory examination;
- Taking other antihypertensive drugs and unwilling to stop;
- Taking folic acid or other Vitamin B groups unwilling to stop.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
756 Patients enrolled
Trial Details
Trial ID
NCT01848873
Start Date
January 1 2013
End Date
August 1 2013
Last Update
May 8 2013
Active Locations (16)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
2
Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100029
3
Peking University First Hospital
Beijing, Beijing Municipality, China, 100036
4
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853