High Dose BAYA1040_Nifedipine: a Dose-comparative Study
NCT ID: NCT01287260
Last Updated: 2014-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
352 participants
INTERVENTIONAL
2011-01-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm1
Nifedipine (Adalat, BAYA1040)
BAYA1040\_Nifedipine 40mg twice daily (BID)
Arm 2
Nifedipine (Adalat, BAYA1040)
BAYA1040\_Nifedipine 40mg once daily (OD)
Interventions
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Nifedipine (Adalat, BAYA1040)
BAYA1040\_Nifedipine 40mg twice daily (BID)
Nifedipine (Adalat, BAYA1040)
BAYA1040\_Nifedipine 40mg once daily (OD)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patients with secondary hypertension or hypertensive emergency
20 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Hirosaki, Aomori, Japan
Kamagaya, Chiba, Japan
Asahikawa, Hokkaido, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kawasaki, Kanagawa, Japan
Daitō, Osaka, Japan
Kishiwada, Osaka, Japan
Yao, Osaka, Japan
Tokorozawa, Saitama, Japan
Shizuoka, Shizuoka, Japan
Hachiōji, Tokyo, Japan
Meguro City, Tokyo, Japan
Minato, Tokyo, Japan
Minato, Tokyo, Japan
Countries
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References
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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.
Other Identifiers
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13176
Identifier Type: -
Identifier Source: org_study_id
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