High Dose BAYA1040_Nifedipine: a Dose-comparative Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01287260
First received: January 30, 2011
Last updated: January 28, 2014
Last verified: January 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01287260     History of Changes
Other Study ID Numbers: 13176
Study First Received: January 30, 2011
Last Updated: January 28, 2014
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
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014