Enalapril Maleate and Folic Acid Tablets for Prevention of Chronic Kidney Diseases in Patients With Hypertension: a Double-blind Randomized Controlled Trial (CSPPT-CKD)

NCT01871740 Phase 4 WITHDRAWN

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.

Details

Lead sponsor	Shenzhen Ausa Pharmed Co.,Ltd
Phase	Phase 4
Status	WITHDRAWN
Start date	2008-05
Completion	2014-08

Conditions

• Hypertension
• Hyperhomocysteinemia

Interventions

• Enalapril maleate and folic acid tablets
• Enalapril maleate

Primary outcomes

• Renal function decline — Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
  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.

Countries

China