check_circleStudy Completed

Hypertension

Bayer Identifier:

18679

ClinicalTrials.gov Identifier:

NCT03194633

EudraCT Number:

Not Available

EU CT Number:

Not Available
Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease with Uncontrolled Hypertension Patients, a prospective, multicenter, observational study

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.

Key Participants Requirements

Sex

All

Age

18 - 70 Years
  • - 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

  • - 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
871
Trial Dates
July 2017 - August 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, China

Primary Outcome

  • Change in office systolic blood pressure from baseline to week 12
    Change in office systolic blood pressure from baseline to week 12
    date_rangeTime Frame:
    At week 12
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in office diastolic blood pressure from baseline to week 12
    Change in office diastolic blood pressure from baseline to week 12
    date_rangeTime Frame:
    At week 12
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    At week 12
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    At week 12
    enhanced_encryption
    Safety Issue:
    No
  • Systolic blood pressure and diastolic blood pressure control rate at week 12
    Systolic blood pressure and diastolic blood pressure control rate at week 12
    date_rangeTime Frame:
    At week 12
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events and serious adverse events
    date_rangeTime Frame:
    At week 12
    enhanced_encryption
    Safety Issue:
    Yes

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
N/A

Additional Information

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