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
ClinicalTrials.gov Identifier:
NCT01050062
First received: December 24, 2009
Last updated: April 4, 2014
Last verified: April 2014
Results First Received: December 18, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hypertension
Interventions: Drug: Telmisartan 80mg
Drug: Telmisartan 40mg
Drug: Hydrochlorothiazide 12.5mg

  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
No text entered.

Reporting Groups
  Description
Combination Tablet AP Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
Combination Tablet BP Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg

Participant Flow:   Overall Study
    Combination Tablet AP     Combination Tablet BP  
STARTED     1070     355  
COMPLETED     799     243  
NOT COMPLETED     271     112  
Adverse Event                 75                 22  
Lost to Follow-up                 83                 35  
Lack of Efficacy                 22                 35  
Physician Decision                 74                 9  
Others                 17                 11  



  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.
The 18 patients which had no information including safety due to no visit after enrolled, were excluded from the safety analysis, 1,425 patients were included in the safety set.

Reporting Groups
  Description
Combination Tablet AP Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
Combination Tablet BP Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
Total Total of all reporting groups

Baseline Measures
    Combination Tablet AP     Combination Tablet BP     Total  
Number of Participants  
[units: participants]
  1070     355     1425  
Age  
[units: years]
Mean ± Standard Deviation
  68.6  ± 12.0     69.8  ± 12.5     68.9  ± 12.2  
Gender  
[units: Number¬†of¬†participants]
     
Female     570     186     756  
Male     500     169     669  



  Outcome Measures
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1.  Primary:   Incidence of Adverse Events (AEs)   [ Time Frame: Week 52 ]

2.  Secondary:   Systolic Blood Pressure (SBP)   [ Time Frame: Week 0 and Week 52 ]

3.  Secondary:   Diastolic Blood Pressure (DBP)   [ Time Frame: Week 0 and Week 52 ]

4.  Secondary:   Target Blood Pressure Achievement Rate   [ Time Frame: Week 52 ]

5.  Secondary:   Blood Pressure Normalised Rate   [ Time Frame: Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
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: April 4, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare