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Trial record 1 of 1 for:    NCT01287260
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High Dose BAYA1040_Nifedipine: a Dose-comparative Study

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ClinicalTrials.gov Identifier: NCT01287260
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : January 29, 2014
Information provided by (Responsible Party):

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

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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

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 :
  1. Efficacy changes measured by sitting diastolic blood pressure (DBP) [ Time Frame: Up to 8 weeks ]

Secondary Outcome Measures :
  1. Efficacy changes measured by sitting systolic blood pressure (SBP) [ Time Frame: Up to 8 weeks ]
  2. 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 ]
  3. 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

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

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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
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Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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:
Essential hypertension
Japanese Patients
Phase III
Additional relevant MeSH terms:
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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
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