HypertensionPhase 3NCT01355367
High Dose BAYA1040 CR: a Long Term Extension Study
A Phase 3 study testing Nifedipine (Adalat, BAYA1040) in people with Hypertension, run by Bayer at 22 sites in Japan.
Trial summary
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Nifedipine (Adalat, BAYA1040)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 22 sitesJapan
- Study dates
- Jan 2011to Apr 2012
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable
Who cannot join
- Patients with expected difficulties for the continuous 1 year follow up
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Japan22 sites
Study site
Asahikawa, Hokkaido, 070-0061
Study site
Asahikawa, Hokkaido, 078-8214
Study site
Daitō, Osaka, 574-0074
Study site
Hachiōji, Tokyo, 192-0046
Study site
Hirosaki, Aomori, 036-8082
Study site
Kamagaya, Chiba, 273-0100
Study site
Kawasaki, Kanagawa, 210-0852
Study site
Kishiwada, Osaka, 596-8522
Study site
Meguro City, Tokyo, 152-0031
Study site
Minato, Tokyo, 105-7390
Study site
Minato, Tokyo, 108-0075
Study site
Sapporo, Hokkaido, 003-0026
Study site
Sapporo, Hokkaido, 003-0825
Study site
Sapporo, Hokkaido, 004-0004
Study site
Sapporo, Hokkaido, 007-0841
Study site
Sapporo, Hokkaido, 062-0053
Study site
Sapporo, Hokkaido, 063-0841
Study site
Sapporo, Hokkaido, 064-0803
Study site
Sapporo, Hokkaido, 064-0807
Study site
Shizuoka, Shizuoka, 421-0193
Study site
Tokorozawa, Saitama, 359-1141
Study site
Yao, Osaka, 581-0011
About this study
Official title: A Multicenter, Open Label, Long Term Extension Study of Oral BAYA1040 CR 80 mg (40 mg Bid) for 44 Weeks in Patients With Essential Hypertension (Extension From Study 13176)
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.
- Conditions
- Hypertension
- Being tested
- Nifedipine (Adalat, BAYA1040)
- Keywords
- BAYA1040 CR, Nifedipine, Essential hypertension, Japanese Patients, Phase III, Extension study
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine (Adalat, BAYA1040)Drug
BAYA1040 CR 40mg BID
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Nifedipine (Adalat, BAYA1040) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables will be summarized using descriptive statistics based on adverse events collection
Measured: Week 52
Secondary outcomes (4)
Changes from baseline in diastolic blood pressure (DBP) while sitting
Measured: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Changes from baseline in systolic blood pressure (SBP) while sitting
Measured: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Measured: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Measured: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionApr 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT01355367
- Sponsor's protocol ID
- 14023
- Status last verified
- Jan 2014
- First submitted
- 21 Apr 2011
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Long Term Extension Study of Oral BAYA1040 CR 80 mg (40 mg Bid) for 44 Weeks in Patients With Essential Hypertension (Extension From Study 13176)
- ClinicalTrials.gov ID
- NCT01355367
- Acronym / sponsor ID
- 14023
- Conditions
- Hypertension
- Keywords
- BAYA1040 CR, Nifedipine, Essential hypertension, Japanese Patients, Phase III, Extension study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 May 2011 (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.
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Nifedipine (Adalat, BAYA1040) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable
Key exclusion criteria (1 listed)
- Patients with expected difficulties for the continuous 1 year follow up
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, BAYA1040)BAYA1040 CR 40mg BID | Drug | Arm 1 |
Primary outcome
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: Week 52
4 secondary outcomes
Changes from baseline in diastolic blood pressure (DBP) while sitting
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Changes from baseline in systolic blood pressure (SBP) while sitting
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
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 29 Jan 2014.
Related trials for Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruitingPhase 4
A Clinical Study of MK-7962 in Chinese Participants With Pulmonary Arterial Hypertension (MK-7962-022)
Hypertension, Pulmonary
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Not yet recruitingObservational study
Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
Hypertension
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
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nifedipine (Adalat, BAYA1040) in people with Hypertension, run by Bayer at 22 sites in Japan.
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 1 inclusion and 1 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 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Safety variables will be summarized using descriptive statistics based on adverse events collection (time frame: Week 52). 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 29 Jan 2014.