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High Dose BAYA1040 CR: a Long Term Extension Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01355367
First received: April 21, 2011
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  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:

Drug Information available for: Nifedipine
U.S. FDA Resources

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
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, 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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier: NCT01355367     History of Changes
Other Study ID Numbers: 14023
Study First Received: April 21, 2011
Last Updated: February 6, 2013
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
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 22, 2013