HypertensionPhase 4ADEPTNCT02413515
Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapyo-therapy.
A Phase 4 study testing Nifedipine (Adalat GITS, BAY1040) in people with Hypertension, run by Bayer at 14 sites in China.
Trial summary
To evaluate antihypertensive efficacy and tolerability of Nifedipine GITS 60mg treated for 8 weeks in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nifedipine (Adalat GITS, BAY1040)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 14 sitesChina
- Study dates
- 26 Mar 2015to 8 Aug 2016
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible to be included in the study only if they meet all of the following criteria:
- Aged 18 years or older, but less than 65 years;
- Either male or female
- BP is uncontrolled after at least 4 weeks of prior antihypertensive mono-therapy (the dosage of mono-therapy should be the starting dose of an angiotensin receptor blocker (ARB), angiotensin converting enzyme inhibitor (ACEI), b-blocker (BB), calcium channel blocker (CCB), or diuretic) both in the beginning and at the end of the screening period (uncontrolled BP is defined as MSSBP ≥140 and <160mmHg and/or MSDBP ≥ 90 and <100mmHg, and in the presence of diabetes mellitus: MSSBP ≥130 and <160mmHg and/or MSDBP ≥80 and <100mmHg);
Who cannot join
- Subjects meeting any of the following criteria are to be excluded from the study:
- Known hypersensitivity to nifedipine or to any of the following excipients, hypromellose, polyethylene oxide, magnesium stearate, sodium chloride, iron oxide red (E172/C.I.77491), cellulose acetate, polyethylene glycol 3350, hydroxypropyl cellulose, propylene glycol, titanium dioxide (E171/C.I.77891)
- Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
- Severe gastro-intestinal tract narrowing; gastric banding; kock pouch (ileostomy after proctocolectomy)
- Evidence of cardiovascular shock
- Pregnant, possibly pregnant, planning to become pregnant or lactating women Received combination (two or more than two drugs combination) therapy or higher dosage (a higher dosage is defined as a higher dosage than the standard recommended starting dosage presented in the label of each drug) mono-therapy in the beginning or at the ending of the screening period.
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- History of cerebrovascular ischemic event (stroke or transient ischemic attack [TIA]) within 6 months
- History of intracerebral hemorrhage or subarachnoid hemorrhage
- History of hypertensive retinopathy
- Any history of heart failure, New York Heart Association (NYHA) classification III or IV Severe coronary heart disease as manifested by a history of myocardial infarction or unstable angina in the past 12 months or a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- Clinically significant cardiac valvular disease
- History of arrhythmia
- Type 1 diabetes mellitus (DM)
- Hyperkalemia history: a serum potassium level above the upper limit of normal in the laboratory range;
- Liver disease or aspartate transaminase (AST) or alanine transaminase (ALT) levels >3 x upper limit of normal (ULN)
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) of <30 mL/min, or on hemodialysis
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Study site
Beijing, 100028
Study site
Beijing, 100037
Study site
Beijing
Study site
Changsha, Hunan, 410008
Study site
Fuzhou, Fujian, 350001
Study site
Hangzhou, Zhejiang, 310006
Study site
Nanjing, Jiangsu, 210008
Study site
Shandong
Study site
Shanghai, 200025
Study site
Tangshan, Hebei, 063000
Study site
Tangshang
Study site
Tianjin, 300052
Study site
Wudan, Hubei, 430022
Study site
Xi’an, Shanxi, 710061
About this study
Official title: Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapy: A Prospective, Open-label, Multicenter, Single-arm, 8-week Study.
To evaluate antihypertensive efficacy and tolerability of Nifedipine GITS 60mg treated for 8 weeks in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive monotherapy.
Read the detailed description
Study design: it's a A prospective, open-label, multicenter, single-arm study. After a one- to two-week screening period, subjects receive Nifedipine GITS 60mg for 8 weeks.
The primary objective is to evaluate the antihypertensive efficacy of 8-week Nifedipine GITS 60mg treatment in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive mono-therapy.
The secondary objective is to evaluate the tolerability of Nifedipine GITS 60mg.
- Conditions
- Hypertension
- Being tested
- Nifedipine (Adalat GITS, BAY1040)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine (Adalat GITS, BAY1040)Drug
Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Single arm study,the eligible subjects will receive Nifedipine GITS 60mg for 8 weeks Receives: Drug: Nifedipine (Adalat GITS, BAY1040) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with a Mean Sitting Systolic Blood Pressure (<130mmHg for subjects with diabetes and <140mmHg for others) of Nifedipine GITs 60mg
Measured: At week 8
Secondary outcomes (8)
Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8
Measured: baseline and week 8
Percentage of subjects with a Mean Sitting Systolic Blood Pressure Lower than 140mmHg and MSDBP less than 90 mmHg (130 and 80 for diabetis patients) of Nifedipine GITs 60mg
Measured: At week 2 and week 4
The percentage of subjects with a MSDBP lower than 90 (80 for diabetis)
Measured: At week 2 and week 4
The percentage of subjects achieving both a ≥10mmHg
Measured: At week 8
Time to reach the MSSBP target (based on the BP measurements during office visits)
The MSSBP target means : 140 mmHg for others, 130 mmHg for diabetes
Measured: up to week 8
Changes in the 24-h, daytime (from 06:00 to 22:00), and nighttime (from 22:00 to 06:00) average SBP and DBP assessed by ABPM from baseline at Week 8
Measured: baseline and week 8
incidence of all treatment-emergent adverse events
Measured: At week 8
incidence of drug-related treatment-emergent adverse events
Measured: at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study start26 Mar 2015
- Primary completion8 Aug 2016
- Study completion8 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 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
- NCT02413515
- Sponsor's protocol ID
- 17677
- Acronym
- ADEPT
- Status last verified
- Aug 2017
- First submitted
- 2 Apr 2015
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapy: A Prospective, Open-label, Multicenter, Single-arm, 8-week Study.
- ClinicalTrials.gov ID
- NCT02413515
- Acronym / sponsor ID
- ADEPT / 17677
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- 8 Aug 2016 (actual)
- Study completion
- 8 Aug 2016 (actual)
- First posted
- 10 Apr 2015 (estimated)
- 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.
To evaluate antihypertensive efficacy and tolerability of Nifedipine GITS 60mg treated for 8 weeks in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive monotherapy.
Detailed description
Study design: it's a A prospective, open-label, multicenter, single-arm study. After a one- to two-week screening period, subjects receive Nifedipine GITS 60mg for 8 weeks.
The primary objective is to evaluate the antihypertensive efficacy of 8-week Nifedipine GITS 60mg treatment in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive mono-therapy.
The secondary objective is to evaluate the tolerability of Nifedipine GITS 60mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Nifedipine (Adalat GITS, BAY1040)Single arm study,the eligible subjects will receive Nifedipine GITS 60mg for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are eligible to be included in the study only if they meet all of the following criteria:
- Aged 18 years or older, but less than 65 years;
- Either male or female
- BP is uncontrolled after at least 4 weeks of prior antihypertensive mono-therapy (the dosage of mono-therapy should be the starting dose of an angiotensin receptor blocker (ARB), angiotensin converting enzyme inhibitor (ACEI), b-blocker (BB), calcium channel blocker (CCB), or diuretic) both in the beginning and at the end of the screening period (uncontrolled BP is defined as MSSBP ≥140 and <160mmHg and/or MSDBP ≥ 90 and <100mmHg, and in the presence of diabetes mellitus: MSSBP ≥130 and <160mmHg and/or MSDBP ≥80 and <100mmHg);
Key exclusion criteria (16 listed)
- Subjects meeting any of the following criteria are to be excluded from the study:
- Known hypersensitivity to nifedipine or to any of the following excipients, hypromellose, polyethylene oxide, magnesium stearate, sodium chloride, iron oxide red (E172/C.I.77491), cellulose acetate, polyethylene glycol 3350, hydroxypropyl cellulose, propylene glycol, titanium dioxide (E171/C.I.77891)
- Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
- Severe gastro-intestinal tract narrowing; gastric banding; kock pouch (ileostomy after proctocolectomy)
- Evidence of cardiovascular shock
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 (Adalat GITS, BAY1040)Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment | Drug | Arm 1 |
Primary outcome
Percentage of subjects with a Mean Sitting Systolic Blood Pressure (<130mmHg for subjects with diabetes and <140mmHg for others) of Nifedipine GITs 60mg
Time frame: At week 8
8 secondary outcomes
Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8
Time frame: baseline and week 8
Percentage of subjects with a Mean Sitting Systolic Blood Pressure Lower than 140mmHg and MSDBP less than 90 mmHg (130 and 80 for diabetis patients) of Nifedipine GITs 60mg
Time frame: At week 2 and week 4
The percentage of subjects with a MSDBP lower than 90 (80 for diabetis)
Time frame: At week 2 and week 4
The percentage of subjects achieving both a ≥10mmHg
Time frame: At week 8
Time to reach the MSSBP target (based on the BP measurements during office visits)
Time frame: up to week 8
Changes in the 24-h, daytime (from 06:00 to 22:00), and nighttime (from 22:00 to 06:00) average SBP and DBP assessed by ABPM from baseline at Week 8
Time frame: baseline and week 8
incidence of all treatment-emergent adverse events
Time frame: At week 8
incidence of drug-related treatment-emergent adverse events
Time frame: at week 8
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 4 Aug 2017.
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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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifedipine (Adalat GITS, BAY1040) in people with Hypertension, run by Bayer at 14 sites 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 4 inclusion and 16 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 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of subjects with a Mean Sitting Systolic Blood Pressure (<130mmHg for subjects with diabetes and <140mmHg for others) of Nifedipine GITs 60mg (time frame: At week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2017.