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Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01050062
First received: December 24, 2009
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
Results First Received: December 18, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hypertension
Intervention: Drug: Micombi Combination Tablets

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 1452 patients were enrolled. Of these patients, the CRFs of 9 patients were uncollected by reason of institution, and the 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Micombi Tablets Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg

Participant Flow:   Overall Study
    Micombi Tablets  
STARTED     1425  
COMPLETED     1042  
NOT COMPLETED     383  
Adverse Event                 97  
Lost to Follow-up                 118  
Withdrawal by Subject                 140  
Unkown                 28  



  Baseline Characteristics
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Reporting Groups
  Description
Micombi Tablets Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg

Baseline Measures
    Micombi Tablets  
Number of Participants  
[units: participants]
 		  1425  
Age  
[units: years]
Mean ± Standard Deviation 		  68.9  ± 12.2  
Gender  
[units: Number of participants]
 		 
Female     756  
Male     669  



  Outcome Measures
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1.  Primary:   Incidence of Adverse Events (AEs)   [ Time Frame: Week 52 ]
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2.  Secondary:   Systolic Blood Pressure (SBP)   [ Time Frame: Week 0 and Week 52 ]
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3.  Secondary:   Diastolic Blood Pressure (DBP)   [ Time Frame: Week 0 and Week 52 ]
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4.  Secondary:   Target Blood Pressure Achievement Rate   [ Time Frame: Week 52 ]
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5.  Secondary:   Blood Pressure Normalised Rate   [ Time Frame: Week 52 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
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Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01050062     History of Changes
Other Study ID Numbers: 502.542
Study First Received: December 24, 2009
Results First Received: December 18, 2012
Last Updated: February 13, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare