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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

January 30, 2011
January 28, 2014
January 2011
August 2011   (final data collection date for primary outcome measure)
Efficacy changes measured by sitting diastolic blood pressure (DBP) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01287260 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
High Dose BAYA1040_Nifedipine: a Dose-comparative Study
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: Nifedipine (Adalat, BAYA1040)
    BAYA1040_Nifedipine 40mg twice daily (BID)
  • Drug: Nifedipine (Adalat, BAYA1040)
    BAYA1040_Nifedipine 40mg once daily (OD)
  • Experimental: Arm1
    Intervention: Drug: Nifedipine (Adalat, BAYA1040)
  • Active Comparator: Arm 2
    Intervention: Drug: Nifedipine (Adalat, BAYA1040)
Shimamoto K, Hasebe N, Ito S, Kario K, Kimura K, Dohi Y, Kawano Y, Rakugi H, Horiuchi M, Imaizumi T, Ohya Y. Nifedipine controlled-release 40 mg b.i.d. in Japanese patients with essential hypertension who responded insufficiently to nifedipine controlled-release 40 mg q.d.: a phase III, randomized, double-blind and parallel-group study. Hypertens Res. 2014 Jan;37(1):69-75. doi: 10.1038/hr.2013.80. Epub 2013 Aug 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
352
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01287260
13176
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