Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study

Hypertension Clinical Trial

— ADRENAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194633
• Other study ID #: 18679
• Status: Completed
• Start date: July 10, 2017
• Est. completion date: August 28, 2020

Study information

• Verified date: July 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 871
• Est. completion date: August 28, 2020
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)
Nifedipine GITS 60 mg (once per day)

Locations

Country	Name	City	State
China	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	At week 12
Secondary	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
Secondary	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
Secondary	Number of participants with adverse events and serious adverse events		At week 12

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