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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine (Adalat, BAYA1040) | Drug | BAYA1040_Nifedipine 40mg twice daily (BID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy changes measured by sitting diastolic blood pressure (DBP) | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy changes measured by sitting systolic blood pressure (SBP) | Up to 8 weeks | |
| Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines | Up to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hirosaki | Aomori | 036-8082 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23945965 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Nifedipine (Adalat, BAYA1040) |
| Drug |
BAYA1040_Nifedipine 40mg once daily (OD) |
|
| Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP | Up to 8 weeks |
| Kamagaya |
| Chiba |
| 273-0100 |
| Japan |
| Asahikawa | Hokkaido | 070-0061 | Japan |
| Asahikawa | Hokkaido | 078-8214 | Japan |
| Sapporo | Hokkaido | 003-0026 | Japan |
| Sapporo | Hokkaido | 003-0825 | Japan |
| Sapporo | Hokkaido | 004-0004 | Japan |
| Sapporo | Hokkaido | 007-0841 | Japan |
| Sapporo | Hokkaido | 062-0053 | Japan |
| Sapporo | Hokkaido | 063-0841 | Japan |
| Sapporo | Hokkaido | 064-0803 | Japan |
| Sapporo | Hokkaido | 064-0807 | Japan |
| Kawasaki | Kanagawa | 210-0852 | Japan |
| Daitō | Osaka | 574-0074 | Japan |
| Kishiwada | Osaka | 596-8522 | Japan |
| Yao | Osaka | 581-0011 | Japan |
| Tokorozawa | Saitama | 359-1141 | Japan |
| Shizuoka | Shizuoka | 421-0193 | Japan |
| Hachiōji | Tokyo | 192-0046 | Japan |
| Meguro City | Tokyo | 152-0031 | Japan |
| Minato | Tokyo | 105-7390 | Japan |
| Minato | Tokyo | 108-0075 | Japan |