Status:
WITHDRAWN
CSPPT- Chronic Kidney Diseases Study
Lead Sponsor:
Shenzhen Ausa Pharmed Co.,Ltd
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Conditions:
Hypertension
Hyperhomocysteinemia
Eligibility:
All Genders
45-75 years
Phase:
PHASE4
Brief Summary
The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing renal function decline among the patients with primary hypertension when compared ...
Detailed Description
Elevated blood concentration of homocysteine (Hcy) has been suggested as a modifiable, independent risk factor for coronary artery disease, stroke, and deep vein thrombosis. Prevalence of hyperhomocys...
Eligibility Criteria
Inclusion
- BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment;
- 45-75 years old;
- Successful determination of methylenetetrahydrofolate reductase (MTHFR) C677T genotype;
- For pre-menopausal women, agreed to use contraceptives during the trial;
- Signed the written informed consent.
Exclusion
- Having a history of stroke;
- Having a history of myocardial infarction;
- Having a history of physician diagnosed heart failure;
- Post- coronary revascularization;
- Severe somatic disease such as cancer;
- Secondary hypertension;
- Congenital or acquired organic heart diseases;
- Contraindicated to angiotensin-converting enzyme inhibitor (ACEI);
- Having a history of ACEI adverse effects;
- Currently long-term use of folic acid or vitamin B12 or vitamin B6;
- Pregnant or child breastfeeding women;
- Severe mental disorders;
- Lab tests indicating abnormal liver or kidney function;
- Unwilling to participate the trial;
- Unwilling to change the current antihypertensive treatment.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01871740
Start Date
May 1 2008
End Date
August 1 2014
Last Update
January 20 2016
Active Locations (2)
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1
Anqing Branch, Anhui Institute of Biomedical Research
Anqing, Anhui, China, 246000
2
Lianyungang Center for Advanced Research in Cardiovascular Diseases
Lianyungang, Jiangsu, China, 222003