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High Dose BAYA1040 CR: a Long Term Extension Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355367
First Posted: May 18, 2011
Last Update Posted: January 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
April 21, 2011
May 18, 2011
January 29, 2014
January 2011
September 2011   (Final data collection date for primary outcome measure)
Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: Week 52 ]
Same as current
Complete list of historical versions of study NCT01355367 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
High Dose BAYA1040 CR: a Long Term Extension Study
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension
Drug: Nifedipine (Adalat, BAYA1040)
BAYA1040 CR 40mg BID
Experimental: Arm 1
Intervention: Drug: Nifedipine (Adalat, BAYA1040)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
April 2012
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01355367
14023
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP