Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00768560
First received: October 7, 2008
Last updated: May 28, 2013
Last verified: May 2013
Results First Received: September 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD
Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BID
Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
47 subjects were recruited from 30 Jan 2008 to 11 May 2008 by 3 centers in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a 4-week baseline treatment with Adalat controlled release (CR) 40 mg once daily (OD), 35 subjects were randomized to double-blind treatment and were included in the safety analysis. 34 subjects were included in the analysis of pharmacokinetics, efficacy and demographic data. 1 subject discontinued the study in Period 1 due to adverse event.

Reporting Groups
  Description
Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each No text entered.
Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each No text entered.
Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each No text entered.
Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each No text entered.
Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each No text entered.
Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each No text entered.

Participant Flow for 3 periods

Period 1:   Intervention Set 1
    Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each     Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each     Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each     Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each     Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each     Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each  
STARTED     5 [1]   6 [1]   6 [1]   6 [1]   6 [1]   6 [1]
Subjects Received Treatment     5 [2]   6 [2]   6 [3]   6 [4]   6 [5]   6 [5]
COMPLETED     5     5     6     6     6     6  
NOT COMPLETED     0     1     0     0     0     0  
Adverse Event                 0                 1                 0                 0                 0                 0  
[1] 3-period/treatment crossover
[2] 40 mg OD for 2 weeks
[3] 40 mg twice daily (BID) for 2 weeks
[4] 40 mg BID for 2 weeks
[5] 80 mg OD for 2 weeks

Period 2:   Intervention Set 2
    Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each     Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each     Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each     Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each     Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each     Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each  
STARTED     5 [1]   5 [2]   6 [2]   6 [3]   6 [3]   6 [1]
COMPLETED     5     5     6     6     6     6  
NOT COMPLETED     0     0     0     0     0     0  
[1] 40 mg BID for 2 weeks
[2] 80 mg OD for 2 weeks
[3] 40 mg OD for 2 weeks

Period 3:   Intervention Set 3
    Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each     Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each     Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each     Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each     Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each     Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each  
STARTED     5 [1]   5 [2]   6 [3]   6 [1]   6 [2]   6 [3]
COMPLETED     5     5     6     6     6     6  
NOT COMPLETED     0     0     0     0     0     0  
[1] 80 mg OD for 2 weeks
[2] 40 mg BID for 2 weeks
[3] 40 mg OD for 2 weeks



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each No text entered.
Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each No text entered.
Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each No text entered.
Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each No text entered.
Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each No text entered.
Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each No text entered.
Total Total of all reporting groups

Baseline Measures
    Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each     Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each     Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each     Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each     Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each     Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each     Total  
Number of Participants  
[units: participants]
  5     5     6     6     6     6     34  
Age  
[units: years]
Mean ( Full Range )
  61.4  
  ( 55 to 68 )  
  63.6  
  ( 55 to 73 )  
  59.7  
  ( 55 to 65 )  
  64.3  
  ( 60 to 70 )  
  58.2  
  ( 37 to 67 )  
  59.7  
  ( 56 to 68 )  
  61.1  
  ( 37 to 73 )  
Gender  
[units: participants]
             
Female     1     3     0     2     1     1     8  
Male     4     2     6     4     5     5     26  
Blood Pressure (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) at Baseline [1]
[units: mm Hg]
Mean ± Standard Deviation
             
SBP at baseline     150.00  ± 7.91     161.00  ± 16.67     156.33  ± 11.18     155.83  ± 10.96     156.33  ± 14.79     154.83  ± 13.53     155.89  ± 12.38  
DBP at baseline     94.40  ± 4.98     95.00  ± 6.60     98.00  ± 6.45     91.00  ± 7.07     92.50  ± 3.45     89.83  ± 7.68     93.43  ± 6.40  
Heart rate (HR) at Baseline [2]
[units: beats / min]
Mean ± Standard Deviation
  64.20  ± 6.18     72.67  ± 13.95     79.00  ± 10.81     70.83  ± 5.42     68.50  ± 7.87     79.50  ± 17.84     72.69  ± 11.83  
[1] Blood pressure (BP) before the start of baseline treatment. Subjects valid for safety analysis
[2] Heart rate (HR) before the start of baseline treatment. Subjects valid for safety analysis



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change of Sitting Blood Pressure   [ Time Frame: Baseline and after 2 weeks treatment ]

2.  Secondary:   Differences of Systolic Blood Pressure Profile   [ Time Frame: Baseline and after 2 weeks treatment ]

3.  Secondary:   Differences of Diastolic Blood Pressure Profile   [ Time Frame: Baseline and after 2 weeks treatment ]

4.  Secondary:   Target Blood Pressure Achievement in Elderly (≥65)   [ Time Frame: After 2 weeks treatment ]

5.  Secondary:   Target Blood Pressure Achievement in Non-elderly (<65)   [ Time Frame: After 2 weeks treatment ]

6.  Secondary:   Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder   [ Time Frame: After 2 weeks treatment ]

7.  Secondary:   Target Blood Pressure Achievement in All Subjects   [ Time Frame: After 2 weeks treatment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Head Clinical Pharmacology, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT00768560     History of Changes
Other Study ID Numbers: 13012
Study First Received: October 7, 2008
Results First Received: September 28, 2009
Last Updated: May 28, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency