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

NCT03194633 | Completed

• 1 other identifier: 18679
• Study Type: observational
• Target: 871
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  At week 12

• Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 at different stages of Chronic Kidney Disease

  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

Study Arms (1)

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.

Drug: Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)

Interventions

Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040) DRUG

Nifedipine GITS 60 mg (once per day)

Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are prescribed 60-mg nifedipine GITS (once per day) and meet the inclusion/exclusion criteria will be enrolled into the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, China

Location

Related Publications (1)

• 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.

  PMID: 34331258 DERIVED

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Hypertension

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 21, 2017
• Study Start: July 10, 2017
• Primary Completion: May 14, 2020
• Study Completion: August 28, 2020
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

CN (1)