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

December 24, 2009
April 4, 2014
January 2010
December 2011   (final data collection date for primary outcome measure)
Incidence of Adverse Events (AEs) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
The number of patient with any AEs, patients with drug-related AEs
The primary end point is to confirm safety (Adverse event) and antihypertensive effect on the long term use in daily clinical settings. [ Time Frame: 12months ]
Complete list of historical versions of study NCT01050062 on ClinicalTrials.gov Archive Site
  • Systolic Blood Pressure (SBP) [ Time Frame: Week 0 and Week 52 ] [ Designated as safety issue: No ]
    SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.
  • Diastolic Blood Pressure (DBP) [ Time Frame: Week 0 and Week 52 ] [ Designated as safety issue: No ]
    DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.
  • Target Blood Pressure Achievement Rate [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for >= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.
  • Blood Pressure Normalised Rate [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009
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Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use
Post Marketing Surveillance on Long Drug Use of Micombi Combination Tablets in Patients With Hypertension

The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

1000

Hypertension
  • Drug: Telmisartan 80mg
    Combination tablet
  • Drug: Telmisartan 40mg
    Combination tablet
  • Drug: Hydrochlorothiazide 12.5mg
    Combination tablet
  • Micombi® Combination Tablet AP
    Interventions:
    • Drug: Telmisartan 40mg
    • Drug: Hydrochlorothiazide 12.5mg
  • Micombi® Combination Tablet BP
    Interventions:
    • Drug: Telmisartan 80mg
    • Drug: Hydrochlorothiazide 12.5mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1452
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

Hypertensive patients who have never taken Micombi Tablets.

Exclusion criteria:

None

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01050062
502.542
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Astellas Pharma Inc
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP