Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-08 @ 8:49 PM
Study NCT ID:
NCT03194633
Status:
COMPLETED
Last Update Posted:
2021-07-09
First Post:
2017-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADRENAL
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: