High Dose BAYA1040 CR: a Long Term Extension Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01355367
First received: April 21, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.


Condition Intervention Phase
Hypertension
Drug: Nifedipine (Adalat, BAYA1040)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Long Term Extension Study of Oral BAYA1040 CR 80 mg (40 mg Bid) for 44 Weeks in Patients With Essential Hypertension (Extension From Study 13176)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes from baseline in diastolic blood pressure (DBP) while sitting [ Time Frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 ] [ Designated as safety issue: No ]
  • Changes from baseline in systolic blood pressure (SBP) while sitting [ Time Frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines [ Time Frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP [ Time Frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nifedipine (Adalat, BAYA1040)
BAYA1040 CR 40mg BID

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable

Exclusion Criteria:

  • Patients with expected difficulties for the continuous 1 year follow up
  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: NCT01355367

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, 062-0053
Sapporo, Hokkaido, Japan, 063-0841
Sapporo, Hokkaido, Japan, 064-0807
Sapporo, Hokkaido, Japan, 007-0841
Sapporo, Hokkaido, Japan, 004-0004
Sapporo, Hokkaido, Japan, 003-0825
Sapporo, Hokkaido, Japan, 064-0803
Sapporo, Hokkaido, Japan, 003-0026
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: Bayer
ClinicalTrials.gov Identifier: NCT01355367     History of Changes
Other Study ID Numbers: 14023
Study First Received: April 21, 2011
Last Updated: January 28, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
BAYA1040 CR
Nifedipine
Essential hypertension
Japanese Patients
Phase III
Extension study

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Nifedipine
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Tocolytic Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014