Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040) | Male and female patients with a diagnosis of CKD and hypertension (age, 18-70 years) was enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040) | Drug | Nifedipine GITS 60 mg (once per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in office systolic blood pressure from baseline to week 12 | Change in office systolic blood pressure from baseline to week 12 | At week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in office diastolic blood pressure from baseline to week 12 | Change in office diastolic blood pressure from baseline to week 12 | At week 12 |
| Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 according to baseline SBP stratification |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients who are prescribed 60-mg nifedipine GITS (once per day) and meet the inclusion/exclusion criteria will be enrolled into the study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34331258 | Derived | Lv R, Chen J, Wang H, Wang J, Cheng H, Li R, Li W, Zhang T, Wei L, Chen Q, Huang J, Yu F, Shen S, Wu H, Liu C, Hong F, Liu J, Zhang X, Xiao H, Song W. Effectiveness and Tolerability of Nifedipine GITS in Patients with Chronic Kidney Disease and Uncontrolled Hypertension: A Prospective, Multicenter, Observational Study (ADRENAL). Adv Ther. 2021 Sep;38(9):4771-4785. doi: 10.1007/s12325-021-01850-3. Epub 2021 Jul 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 | 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 | At week 12 |
| Number of participants with adverse events and serious adverse events | At week 12 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided