Trial record 1 of 1 for:
NCT01287260
High Dose BAYA1040_Nifedipine: a Dose-comparative Study
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| ClinicalTrials.gov Identifier: NCT01287260 |
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Recruitment Status :
Completed
First Posted : February 1, 2011
Last Update Posted : January 29, 2014
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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Brief 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 mg once daily treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension | Drug: Nifedipine (Adalat, BAYA1040) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 352 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | January 2011 |
| Actual Primary Completion Date : | August 2011 |
| Actual Study Completion Date : | August 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hypertension
Drug Information available for:
Nifedipine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm1 |
Drug: Nifedipine (Adalat, BAYA1040)
BAYA1040_Nifedipine 40mg twice daily (BID) |
| Active Comparator: Arm 2 |
Drug: Nifedipine (Adalat, BAYA1040)
BAYA1040_Nifedipine 40mg once daily (OD) |
Primary Outcome Measures :
- Efficacy changes measured by sitting diastolic blood pressure (DBP) [ Time Frame: Up to 8 weeks ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287260
Locations
| Japan | |
| Hirosaki, Aomori, Japan, 036-8082 | |
| Kamagaya, Chiba, Japan, 273-0100 | |
| Asahikawa, Hokkaido, Japan, 070-0061 | |
| Asahikawa, Hokkaido, Japan, 078-8214 | |
| Sapporo, Hokkaido, Japan, 003-0026 | |
| Sapporo, Hokkaido, Japan, 003-0825 | |
| Sapporo, Hokkaido, Japan, 004-0004 | |
| Sapporo, Hokkaido, Japan, 007-0841 | |
| Sapporo, Hokkaido, Japan, 062-0053 | |
| Sapporo, Hokkaido, Japan, 063-0841 | |
| Sapporo, Hokkaido, Japan, 064-0803 | |
| Sapporo, Hokkaido, Japan, 064-0807 | |
| Kawasaki, Kanagawa, Japan, 210-0852 | |
| Daito, Osaka, Japan, 574-0074 | |
| Kishiwada, Osaka, Japan, 596-8522 | |
| Yao, Osaka, Japan, 581-0011 | |
| Tokorozawa, Saitama, Japan, 359-1141 | |
| Hachioji, Tokyo, Japan, 192-0046 | |
| Meguro, Tokyo, Japan, 152-0031 | |
| Minato, Tokyo, Japan, 105-7390 | |
| Minato, Tokyo, Japan, 108-0075 | |
| Shizuoka, Japan, 421-0193 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01287260 |
| Other Study ID Numbers: |
13176 |
| First Posted: | February 1, 2011 Key Record Dates |
| Last Update Posted: | January 29, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Bayer:
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BAYA1040_Nifedipine Nifedipine Essential hypertension |
Japanese Patients Phase III 13176 |
Additional relevant MeSH terms:
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Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases Nifedipine Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Tocolytic Agents Reproductive Control Agents |