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Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

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ClinicalTrials.gov Identifier: NCT00659607
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : October 22, 2009
Last Update Posted : June 6, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:

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

Condition or disease
Hypertension

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Study Type : Observational
Actual Enrollment : 6901 participants
Time Perspective: Prospective
Official Title: PMS Study of MicardisPlus Tablet
Study Start Date : September 2003
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitals and clinics in Korea
Criteria

Inclusion Criteria:

patients diagnosed with essential hypertension

Exclusion Criteria:

patients who took Micardis Plus before participating in this PMS study


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): NCT00659607


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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00659607     History of Changes
Other Study ID Numbers: 502.475
First Posted: April 16, 2008    Key Record Dates
Results First Posted: October 22, 2009
Last Update Posted: June 6, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases