Trial Condition(s):

Hypertension

Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease with Uncontrolled Hypertension Patients, a prospective, multicenter, observational study (ADRENAL)

Bayer Identifier:

18679

ClinicalTrials.gov Identifier:

NCT03194633

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Male and female patients aged 18–70 years
- Patients diagnosed with CKD (Estimated Glomerular Filtration Rate (eGFR) >15 mL/min/1.73 m*2) and hypertension without dialysis/replacement therapy 
- Patients with uncontrolled hypertension (office SBP ≥140 mmHg and DBP ≥ 80 mmHg) who have received Renin-Angiotensin System Inhibitors (RASI) treatment or have not received RASI treatment because of any contraindications 
- Patients who haven’t received nifedipine GITS 60 mg (once per day) previously
- Patients for whom the decision to initiate treatment with nifedipine GITS 60 mg was made as per the investigator’s routine treatment practice
- Signed informed consent
- No participation in an investigational program with interventions outside of routine clinical practice
Exclusion Criteria
- Have a contraindication to nifedipine GITS according to the approved prescribing information
- Patients participating in an investigational program with interventions outside of routine clinical practice

Trial Summary

Enrollment Goal
871
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, China

Status
Completed
 

Trial Design