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Trial record 22 of 143 for:    NIFEDIPINE

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

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ClinicalTrials.gov Identifier: NCT03194633
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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 is to evaluate the effectiveness and tolerability of nifedipine GITS 60 mg treatment in a large cohort of CKD patients with uncontrolled hypertension.


Condition or disease Intervention/treatment
Hypertension Drug: Nifedipine controlled-release tablets (Adalat, BAYA1040)

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Study Type : Observational
Estimated Enrollment : 1023 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Nifedipine

Group/Cohort Intervention/treatment
Nifedipine controlled-release tablets(Adalat, BAYA1040)
Male and female patients with a diagnosis of CKD and hypertension (age, 18-70 years) will be enrolled.
Drug: Nifedipine controlled-release tablets (Adalat, BAYA1040)
Nifedipine GITS 60 mg (once per day)




Primary Outcome Measures :
  1. Change in office systolic blood pressure from baseline to week 12 [ Time Frame: At week 12 ]
    Change in office systolic blood pressure from baseline to week 12


Secondary Outcome Measures :
  1. Change in office diastolic blood pressure from baseline to week 12 [ Time Frame: At week 12 ]
    Change in office diastolic blood pressure from baseline to week 12

  2. Change in systolic blood pressure and diastolic blood pressure from baseline to week12 according to baseline BP stratification [ Time Frame: At week 12 ]
    Change in systolic blood pressure and diastolic blood pressure from baseline to week12 according to baseline BP stratification, stratified by two subgroups baseline, SBP 140-160 mmHg and ≥ 160 mmHg

  3. Change in systolic blood pressure and diastolic blood pressure from baseline to week12 at different stages of Chronic Kidney Disease [ Time Frame: At week 12 ]
    Change in systolic blood pressure and diastolic blood pressure from baseline to week12 at different stages of Chronic Kidney Disease, stage 1 to stage 5

  4. Systolic blood pressure and diastolic blood pressure control rate at week 12 [ Time Frame: At week 12 ]
    Systolic blood pressure and diastolic blood pressure control rate at week 12

  5. Number of participants with adverse events and serious adverse events [ Time Frame: At week 12 ]
    Number of participants with adverse events and serious adverse events



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194633


Contacts
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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
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China
Many Locations Recruiting
Multiple Locations, China
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03194633     History of Changes
Other Study ID Numbers: 18679
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nifedipine
Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents