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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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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



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