HypertensionPhase 3NCT01294215
High Dose BAYA1040_Nifedipine: a Long Term Combination Study
A Phase 3 study testing Nifedipine (Adalat, BAYA1040) in people with Hypertension, run by Bayer at 4 sites in Japan.
Trial summary
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and… 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
- 72 participants
- Where
- 4 sitesJapan
- Study dates
- Feb 2011to Jun 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
- 20 years or older
- Japanese male or female
- Outpatient with essential hypertension
- Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study
Who cannot join
- Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more
- Patients with secondary hypertension or hypertensive emergency
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Ebina, Kanagawa, 243-0401
Study site
Kawaguchi, Saitama, 332-0012
Study site
Sagamihara, Kanagawa, 252-0311
Study site
Shinjuku, Tokyo, 169-0072
About this study
Official title: A Multicenter, Open Label, Long Term Study of Oral BAYA1040_CR 80 mg (40 mg Bid) in Combination With Other Antihypertensives for 52 Weeks in Patients With Essential Hypertension
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.
- Conditions
- Hypertension
- Being tested
- Nifedipine (Adalat, BAYA1040)
- Keywords
- BAYA1040, Nifedipine, Essential hypertension, Japanese Patients, Phase III, combination study, 14024
- 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
Nifedipine (Adalat, BAYA1040) 40mg twice a day (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.
Efficacy changes measured by sitting diastolic blood pressure (DBP)
Measured: Up to 52 weeks
Secondary outcomes (4)
Efficacy changes measured by sitting systolic blood pressure (SBP)
Measured: Up to 52 weeks
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Measured: Up to 52 weeks
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Measured: Up to 52 weeks
Safety variables
Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated.
Measured: Up to 30 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionJun 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
- 72 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
- NCT01294215
- Sponsor's protocol ID
- 14024
- Status last verified
- Jun 2014
- First submitted
- 10 Feb 2011
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Long Term Study of Oral BAYA1040_CR 80 mg (40 mg Bid) in Combination With Other Antihypertensives for 52 Weeks in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01294215
- Acronym / sponsor ID
- 14024
- Conditions
- Hypertension
- Keywords
- BAYA1040, Nifedipine, Essential hypertension, Japanese Patients, Phase III, combination study, 14024
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 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 safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.
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 (4 listed)
- 20 years or older
- Japanese male or female
- Outpatient with essential hypertension
- Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study
Key exclusion criteria (2 listed)
- Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg 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)Nifedipine (Adalat, BAYA1040) 40mg twice a day (BID) | Drug | Arm 1 |
Primary outcome
Efficacy changes measured by sitting diastolic blood pressure (DBP)
Time frame: Up to 52 weeks
4 secondary outcomes
Efficacy changes measured by sitting systolic blood pressure (SBP)
Time frame: Up to 52 weeks
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Time frame: Up to 52 weeks
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 52 weeks
Safety variables
Time frame: Up to 30 days after the last dose of study drug
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 23 Jun 2014.
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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
4 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 4 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 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 52 weeks). 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 23 Jun 2014; AzTrials last refreshed its copy on 3 Nov 2026.