A Phase 4 interventional study of Enalapril maleate and folic acid tablets and Enalapril maleate in Hypertension and Hyperhomocysteinemia, sponsored by Shenzhen Ausa Pharmed Co.,Ltd. Withdrawn at 2 sites in China. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-20.
Sponsored by Shenzhen Ausa Pharmed Co.,Ltd · Phase 4, Interventional, and Prevention
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.
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 hyperhomocysteinemia and folic acid deficiency in China are significantly higher than those in Europe and USA. The investigators' preliminary research demonstrated that blood concentration of Hcy was negatively correlated to estimated glomerular filtration rate (eGFR), a key index of kidney function. However, the question as to whether Hcy-lowering therapy with folic acid can reduce the risk of chronic kidney disease(CKD) remains to be answered.
This study, exploiting the hypertensive population of CSPPT trial (ClinicalTrials.gov register number: NCT00794885), is intended to compare the effects of enalapril maleate and folic acid tablets versus enalapril maleate in preventing renal function decline among the patients with primary hypertension. The results from this trial may have the potential to transform current clinical and public health findings into practice in the prevention of chronic kidney disease(CKD) in China.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
Browse Hypertension studies →Shenzhen Ausa Pharmed Co.,Ltd is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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A fixed combination drug is given. The dose is fixed in enalapril 10 mg / folic acid 0.8 mg per day.
Drug: Enalapril maleate and folic acid tablets
Enalapril maleate 10 mg per day is given
Drug: Enalapril maleate
Drug pages: Enalapril · Folic Acid
Enalapril maleate and folic acid tablets, (10mg/0.8mg)/tablet, taken orally and once daily for a maximum of 5 years. Combination with other anti-hypertension drugs are allowed.
Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed.
Also known as: Lameiya(Yabao Pharmaceutical)
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.
Time frame: Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
Average decline rate in eGFR (ml/min/1.73m2/yr).
Time frame: Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
New-onset chronic kidney disease based on eGFR（eGFR<60 ml/min/1.73 m2）
Time frame: Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
New-onset albuminuria
Time frame: Albuminuria was examined at baseline and at the final visit (5 years) of the trial.
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.
Time frame: Every 3 months during the trial, up to 5 years
The record gives a start of May 2008, a primary completion of Jun 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Enalapril · Folic Acid
Shenzhen Ausa Pharmed Co.,Ltd