HypertensionPhase 3NCT01287260
High Dose BAYA1040_Nifedipine: a Dose-comparative 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 superiority in efficacy and assess safety and tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040_Nifedipine 40… 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
- 352 participants
- Where
- 22 sitesJapan
- Study dates
- Jan 2011to Aug 2011
- 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
- 20 years or older
- Japanese male or female
- Outpatient with essential hypertension
- Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug
Who cannot join
- Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more
- Patients with secondary hypertension or hypertensive emergency
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, Double-blind, Parallel-group Comparative Study Between Oral BAYA1040_CR 80 mg and 40 mg for 8 Weeks in Patients With Essential Hypertension for Whom Oral BAYA1040_CR 40 mg is Insufficient
This is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.
- Conditions
- Hypertension
- Being tested
- Nifedipine (Adalat, BAYA1040)
- Keywords
- BAYA1040_Nifedipine, Nifedipine, Essential hypertension, Japanese Patients, Phase III, 13176
- 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_Nifedipine 40mg twice daily (BID)
Nifedipine (Adalat, BAYA1040)Drug
BAYA1040_Nifedipine 40mg once daily (OD)
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | Not described Receives: Drug: Nifedipine (Adalat, BAYA1040) |
| Arm 2 | Active comparator | Not described Receives: Drug: Nifedipine (Adalat, BAYA1040) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy changes measured by sitting diastolic blood pressure (DBP)
Measured: Up to 8 weeks
Secondary outcomes (3)
Efficacy changes measured by sitting systolic blood pressure (SBP)
Measured: Up to 8 weeks
Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Measured: Up to 8 weeks
Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 352 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
- NCT01287260
- Sponsor's protocol ID
- 13176
- Status last verified
- Jan 2014
- First submitted
- 30 Jan 2011
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shimamoto K, Hasebe N, Ito S, Kario K, Kimura K, Dohi Y, Kawano Y, Rakugi H, Horiuchi M, Imaizumi T, Ohya Y. Nifedipine controlled-release 40 mg b.i.d. in Japanese patients with essential hypertension who responded insufficiently to nifedipine controlled-release 40 mg q.d.: a phase III, randomized, double-blind and parallel-group study. Hypertens Res. 2014 Jan;37(1):69-75. doi: 10.1038/hr.2013.80. Epub 2013 Aug 15.
PubMed 23945965
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, Double-blind, Parallel-group Comparative Study Between Oral BAYA1040_CR 80 mg and 40 mg for 8 Weeks in Patients With Essential Hypertension for Whom Oral BAYA1040_CR 40 mg is Insufficient
- ClinicalTrials.gov ID
- NCT01287260
- Acronym / sponsor ID
- 13176
- Conditions
- Hypertension
- Keywords
- BAYA1040_Nifedipine, Nifedipine, Essential hypertension, Japanese Patients, Phase III, 13176
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Feb 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 superiority in efficacy and assess safety and tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: Nifedipine (Adalat, BAYA1040) |
| Arm 2 | Active comparator | 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 (4 listed)
- 20 years or older
- Japanese male or female
- Outpatient with essential hypertension
- Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug
Key exclusion criteria (2 listed)
- Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more
- Patients with secondary hypertension or hypertensive emergency
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_Nifedipine 40mg twice daily (BID) | Drug | Arm1 |
| Nifedipine (Adalat, BAYA1040)BAYA1040_Nifedipine 40mg once daily (OD) | Drug | Arm 2 |
Primary outcome
Efficacy changes measured by sitting diastolic blood pressure (DBP)
Time frame: Up to 8 weeks
3 secondary outcomes
Efficacy changes measured by sitting systolic blood pressure (SBP)
Time frame: Up to 8 weeks
Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Time frame: Up to 8 weeks
Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Time frame: Up to 8 weeks
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.
- Derived from this study: PubMed 23945965Shimamoto K, Hasebe N, Ito S, Kario K, Kimura K, Dohi Y, Kawano Y, Rakugi H, Horiuchi M, Imaizumi T, Ohya Y. Nifedipine controlled-release 40 mg b.i.d. in Japanese patients with essential hypertension who responded insufficiently to nifedipine controlled-release 40 mg q.d.: a phase III, randomized, double-blind and parallel-group study. Hypertens Res. 2014 Jan;37(1):69-75. doi: 10.1038/hr.2013.80. Epub 2013 Aug 15.
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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
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 4 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 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?
Efficacy changes measured by sitting diastolic blood pressure (DBP) (time frame: Up to 8 weeks). 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 NCT01287260, 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 29 Jan 2014.