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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, China | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease with Uncontrolled Hypertension Patients, a prospective, multicenter, observational study
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Change in office systolic blood pressure from baseline to week 12Change in office systolic blood pressure from baseline to week 12Timeframe: At week 12
Secondary Outcome
- Change in office diastolic blood pressure from baseline to week 12Change in office diastolic blood pressure from baseline to week 12Timeframe: At week 12
- Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 according to baseline SBP stratificationChange in systolic blood pressure and diastolic blood pressure from baseline to week 12 according to baseline SBP stratification, stratified by two subgroups baseline, SBP 140-160 mmHg and ≥ 160 mmHgTimeframe: At week 12
- Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 at different stages of Chronic Kidney DiseaseChange in systolic blood pressure and diastolic blood pressure from baseline to week 12 at different stages of Chronic Kidney Disease, stage 1 to stage 5Timeframe: At week 12
- Systolic blood pressure and diastolic blood pressure control rate at week 12Systolic blood pressure and diastolic blood pressure control rate at week 12Timeframe: At week 12
- Number of participants with adverse events and serious adverse eventsTimeframe: At week 12
Additional Information
Copyright © Bayer
Powered by
