HypertensionADRENALNCT03194633
Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study
An observational study of Hypertension, run by Bayer at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- Type of treatment
- Pill or oral medicine
- How many people
- 871 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2017to 28 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)Drug
Nifedipine GITS 60 mg (once per day)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in office systolic blood pressure from baseline to week 12
Change in office systolic blood pressure from baseline to week 12
Measured: At week 12
Secondary outcomes (5)
Change in office diastolic blood pressure from baseline to week 12
Change in office diastolic blood pressure from baseline to week 12
Measured: At week 12
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
Measured: 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
Measured: 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
Measured: At week 12
Number of participants with adverse events and serious adverse events
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start10 Jul 2017
- Primary completion14 May 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194633
- Sponsor's protocol ID
- 18679
- Acronym
- ADRENAL
- Status last verified
- Jul 2021
- First submitted
- 20 Jun 2017
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34331258
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03194633
- Acronym / sponsor ID
- ADRENAL / 18679
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040) | – | Drug: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)Nifedipine GITS 60 mg (once per day) | Drug | Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040) |
Primary outcome
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
5 secondary outcomes
Change in office diastolic blood pressure from baseline to week 12
Time frame: At week 12
Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 according to baseline SBP stratification
Time frame: At week 12
Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 at different stages of Chronic Kidney Disease
Time frame: At week 12
Systolic blood pressure and diastolic blood pressure control rate at week 12
Time frame: At week 12
Number of participants with adverse events and serious adverse events
Time frame: At week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Derived from this study: PubMed 34331258Lv 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Bayer at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in office systolic blood pressure from baseline to week 12 (time frame: At week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.