An observational study in Hypertension, sponsored by Bayer. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-09.
Sponsored by Bayer · Observational
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 871 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are prescribed 60-mg nifedipine GITS (once per day) and meet the inclusion/exclusion criteria will be enrolled into the study.
Exclusion Criteria:
Male and female patients with a diagnosis of CKD and hypertension (age, 18-70 years) was enrolled.
Drug: Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)
Nifedipine GITS 60 mg (once per day)
Change in office systolic blood pressure from baseline to week 12
Change in office systolic blood pressure from baseline to week 12
Time frame: At week 12
Change in office diastolic blood pressure from baseline to week 12
Change in office diastolic blood pressure from baseline to week 12
Time frame: At week 12
Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 according to baseline SBP stratification
Change 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 mmHg
Time frame: At week 12
Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 at different stages of Chronic Kidney Disease
Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 at different stages of Chronic Kidney Disease, stage 1 to stage 5
Time frame: At week 12
Systolic blood pressure and diastolic blood pressure control rate at week 12
Systolic blood pressure and diastolic blood pressure control rate at week 12
Time frame: At week 12
Number of participants with adverse events and serious adverse events
Time frame: At week 12
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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