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Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01050062
First Posted: January 15, 2010
Last Update Posted: May 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Boehringer Ingelheim
  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: Telmisartan 80mg Drug: Telmisartan 40mg Drug: Hydrochlorothiazide 12.5mg

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

Further study details as provided by Boehringer Ingelheim:

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


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
Micombi® Combination Tablet AP Drug: Telmisartan 40mg
Combination tablet
Drug: Hydrochlorothiazide 12.5mg
Combination tablet
Micombi® Combination Tablet BP Drug: Telmisartan 80mg
Combination tablet
Drug: Hydrochlorothiazide 12.5mg
Combination tablet

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050062


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01050062     History of Changes
Other Study ID Numbers: 502.542
First Submitted: December 24, 2009
First Posted: January 15, 2010
Results First Submitted: December 18, 2012
Results First Posted: January 30, 2013
Last Update Posted: May 1, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists