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: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Hypertension
Drug: Micombi Combination Tablets

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance on Long Drug Use of Micombi Combination Tablets in Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 weekson administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009


Enrollment: 1452
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with hypertension Drug: Micombi Combination Tablets
telmisartan 40/80mg and hydrochlorothiazide 12.5mg

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

1000

Criteria

Inclusion criteria:

Hypertensive patients who have never taken Micombi Tablets.

Exclusion criteria:

None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050062

  Show 314 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Astellas Pharma Inc
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
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: February 13, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014