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

April 21, 2011
January 28, 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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01355367
14023
No
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