Hypertension Clinical Trial
— CSPPT-CKDOfficial title:
Enalapril Maleate and Folic Acid Tablets for Prevention of Chronic Kidney Diseases in Patients With Hypertension: a Double-blind Randomized Controlled Trial
Verified date | January 2016 |
Source | Shenzhen Ausa Pharmed Co.,Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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 to enalapril maleate.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Anqing Branch, Anhui Institute of Biomedical Research | Anqing | Anhui |
China | Lianyungang Center for Advanced Research in Cardiovascular Diseases | Lianyungang | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Shenzhen Ausa Pharmed Co.,Ltd | Nanfang Hospital of Southern Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal function decline | Renal function decline was defined based on one of more of the following : (1) A certain drop in eGFR, was defined as a drop in GFR category (=90[G1], 60-89[G2], 45-59[G3a], 30-44[G3b], 15-29[G4], <15[G5] ml/min/1.73m2) accompanied by a 25% or greater drop in eGFR from baseline; (2) Rapid progression, was defined as a sustained decline in eGFR of more than 5 ml/min/1.73m2/yr. |
Serum creatinine was examined at baseline and at the final visit (5 years) of the trial. | No |
Secondary | Average decline rate in eGFR (ml/min/1.73m2/yr). | Serum creatinine was examined at baseline and at the final visit (5 years) of the trial. | No | |
Secondary | New-onset chronic kidney disease based on eGFR(eGFR<60 ml/min/1.73 m2) | Serum creatinine was examined at baseline and at the final visit (5 years) of the trial. | No | |
Secondary | New-onset albuminuria | Albuminuria was examined at baseline and at the final visit (5 years) of the trial. | No | |
Secondary | A composite of renal events. | The composite endpoint is consisted of: 1)End stage renal disease (ESRD);2)Doubling of serum creatinine; and 3)Renal disease-induced death. | Every 3 months during the trial, up to 5 years | No |
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