NCT03194633

Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 871 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Chronic kidney disease (CKD) and hypertension are two closely related common chronic diseases that have serious implications to human health. Hypertension is a major cause for progression of renal disease and a risk factor for cardiovascular disease (CVD). Control of Blood Pressure (BP) to target is now considered to be the main goal in the treatment of patients with CKD. In clinical practice, it is difficult for CKD patients with hypertension to achieve systolic BP (SBP) or diastolic BP (DBP) goal; oftentimes, calcium channel blocker (CCB) class of drugs, for example, nifedipine gastrointestinal therapeutic system (GITS), is used in such patients. Previous data have demonstrated nifedipine to be having a significant dose-response relationship; that is, nifedipine 60 mg provided better BP reduction than 30 mg. However, there are limited studies that have evaluated the efficacy and tolerability of nifedipine GITS 60 mg in Chinese CKD patients with hypertension. Hereby, the objective of this study was to evaluate the effectiveness and tolerability of nifedipine GITS 60 mg treatment in a large cohort of CKD patients with uncontrolled hypertension.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)	Nifedipine GITS 60 mg (once per day)

Timeline

• Start date: 2017-07-10
• Primary completion: 2020-05-14
• Completion: 2020-08-28
• First posted: 2017-06-21
• Last updated: 2021-07-09

Locations

1 site across 1 country: China