High Dose BAYA1040_Nifedipine: a Dose-comparative Study
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01287260
First received: January 30, 2011
Last updated: February 6, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Nifedipine (Adalat, BAYA1040) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Nifedipine
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- Efficacy changes measured by sitting diastolic blood pressure (DBP) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy changes measured by sitting systolic blood pressure (SBP) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 352 |
| Study Start Date: | January 2011 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287260
Locations
| Japan | |
| Hirosaki, Aomori, Japan, 036-8082 | |
| Kamagaya, Chiba, Japan, 273-0100 | |
| Asahikawa, Hokkaido, Japan, 078-8214 | |
| Asahikawa, Hokkaido, Japan, 070-0061 | |
| Sapporo, Hokkaido, Japan, 004-0004 | |
| Sapporo, Hokkaido, Japan, 064-0803 | |
| Sapporo, Hokkaido, Japan, 064-0807 | |
| Sapporo, Hokkaido, Japan, 007-0841 | |
| Sapporo, Hokkaido, Japan, 003-0026 | |
| Sapporo, Hokkaido, Japan, 003-0825 | |
| Sapporo, Hokkaido, Japan, 062-0053 | |
| Sapporo, Hokkaido, Japan, 063-0841 | |
| 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, 108-0075 | |
| Minato, Tokyo, Japan, 105-7390 | |
| Shizuoka, Japan, 421-0193 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Head Medical Development Japan, Bayer Yakuhin Ltd. |
| ClinicalTrials.gov Identifier: | NCT01287260 History of Changes |
| Other Study ID Numbers: | 13176 |
| Study First Received: | January 30, 2011 |
| Last Updated: | February 6, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Bayer:
|
BAYA1040_Nifedipine Nifedipine Essential hypertension |
Japanese Patients Phase III 13176 |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Nifedipine Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 16, 2013