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Completed

NCT Number: NCT01050062

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 111, Ageo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hypertensive patients who have never taken Micombi Tablets.

Exclusion criteria

None

Treatment and study plan

Telmisartan 80mg

Drug

Combination tablet

Telmisartan 40mg

Drug

Combination tablet

Hydrochlorothiazide 12.5mg

Drug

Combination tablet

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Week 52

    The number of patient with any AEs, patients with drug-related AEs

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

Post Marketing Surveillance on Long Drug Use of Micombi Combination Tablets in Patients With Hypertension

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 15, 2010
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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