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Completed

NCT Number: NCT00659607

Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:

1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs)) 2. Frequency of incidence and its change in adverse events (AEs) 3. Factors on the safety profile of the study drug 4. Factors on the efficacy profile of the study drug

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 1, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients diagnosed with essential hypertension

Exclusion criteria

patients who took Micardis Plus before participating in this PMS study

Treatment and study plan

Primary outcomes

  1. Unexpected Adverse Events

    Time frame: Up to 6 years

    Occurrence status of unexpected adverse events

  2. Frequency of Adverse Events

    Time frame: Up to 6 years

  3. Change From Baseline in SBP (Systolic Blood Pressure) at Week 2

    Time frame: Baseline and End of Study

    Effect on decrease in systolic blood pressure

  4. Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2

    Time frame: Baseline and End of Study

    Effect on decrease in diastolic blood pressure

  5. Effective Rate

    Time frame: Baseline and End of Study

    Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows:

    Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved)

    Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed)

Secondary outcomes

  1. Gender Factors Affecting the Safety Profile

    Time frame: Up to 6 years

    Occurrence status of adverse events by Gender category of patients

  2. Age Factors Affecting the Safety Profile

    Time frame: Up to 6 years

    Occurrence status of adverse events by Age category of patients

  3. Proportion of Geriatric Population Factor Affecting the Safety Profile

    Time frame: Up to 6 years

    Occurrence status of adverse events by Proportion of geriatric population of patients

  4. Treatment Type Factors Affecting the Safety Profile

    Time frame: Up to 6 years

    Occurrence status of adverse events by Treatment type of patients

  5. Medical History Factors Affecting the Safety Profile

    Time frame: Up to 6 years

    Occurrence status of adverse events by medical history of patients

  6. Concomitant Disease Factors Affecting the Safety Profile

    Time frame: Up to 6 years

    Occurrence status of adverse events by Concomitant disease of patients

  7. Medical History Factors Affecting the Efficacy Profile

    Time frame: Baseline and End of Study

    Efficacy rate by medical characteristic of patients

  8. Previous Medication Factors Affecting the Efficacy Profile

    Time frame: Baseline and End of Study

    Efficacy rate by medical characteristic of patients

  9. Baseline Severity of Hypertension Factors Affecting the Efficacy Profile

    Time frame: Baseline and End of Study

    Efficacy rate by medical characteristic of patients

    Stage 1 (SBP 140~159 mmHg or DBP 90~99 mmHg) Stage 2 (SBP 160~179 mmHg or DBP 100~109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)

  10. Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile

    Time frame: Baseline and End of Study

    Efficacy rate by medical characteristic of patients

    40/12.5mg < daily dose < 80/12.5mg - Because some physicians changed the daily dose based on patient's BP control result, this range exists

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

PMS Study of MicardisPlus Tablet

Important dates

Study start
2003
Primary completion
2008
First posted
Apr 16, 2008
Registry last updated
Jun 6, 2014

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

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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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