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Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01353274
First received: May 9, 2011
Last updated: July 30, 2014
Last verified: July 2014
Results First Received: July 30, 2014  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hypertension
Intervention: Drug: Micamlo

  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
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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
Patients With Hypertension Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration

Participant Flow:   Overall Study
    Patients With Hypertension  
STARTED     1157  
COMPLETED     1129  
NOT COMPLETED     28  
No case report form (CRF) collected                 28  



  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.
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Reporting Groups
  Description
Patients With Hypertension Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration

Baseline Measures
    Patients With Hypertension  
Number of Participants  
[units: participants]
  1109  
Age  
[units: years]
Mean ± Standard Deviation
  66.6  ± 12.6  
Gender  
[units: participants]
 
Female     514  
Male     595  



  Outcome Measures
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1.  Primary:   Incidence of Drug-related Adverse Events   [ Time Frame: 12 months ]

2.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP)   [ Time Frame: after 1, 2, 3, 6, 12 months ]

3.  Secondary:   Change From Baseline in Diastolic Blood Pressure (DBP)   [ Time Frame: after 1, 2, 3, 6, 12 months ]

4.  Secondary:   Proportion of Patients Who Achieved the Target BP   [ Time Frame: after 1, 2, 3, 6, 12 months ]

5.  Secondary:   Proportion of Patients Who Normalised Their BP   [ Time Frame: after 1, 2, 3, 6, 12 months ]


  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:  
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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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: NCT01353274     History of Changes
Other Study ID Numbers: 1235.38
Study First Received: May 9, 2011
Results First Received: July 30, 2014
Last Updated: July 30, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare