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Trial record 56 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

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.
 
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

Tracking Information
First Submitted Date April 10, 2008
First Posted Date April 16, 2008
Results First Submitted Date July 29, 2009
Results First Posted Date October 22, 2009
Last Update Posted Date June 6, 2014
Study Start Date September 2003
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2014)
  • Unexpected Adverse Events [ Time Frame: Up to 6 years ]
    Occurrence status of unexpected adverse events
  • Frequency of Adverse Events [ Time Frame: Up to 6 years ]
  • 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
  • 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
  • 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)
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: May 8, 2014)
  • Gender Factors Affecting the Safety Profile [ Time Frame: Up to 6 years ]
    Occurrence status of adverse events by Gender category of patients
  • Age Factors Affecting the Safety Profile [ Time Frame: Up to 6 years ]
    Occurrence status of adverse events by Age category of patients
  • 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
  • Treatment Type Factors Affecting the Safety Profile [ Time Frame: Up to 6 years ]
    Occurrence status of adverse events by Treatment type of patients
  • Medical History Factors Affecting the Safety Profile [ Time Frame: Up to 6 years ]
    Occurrence status of adverse events by medical history of patients
  • Concomitant Disease Factors Affecting the Safety Profile [ Time Frame: Up to 6 years ]
    Occurrence status of adverse events by Concomitant disease of patients
  • Medical History Factors Affecting the Efficacy Profile [ Time Frame: Baseline and End of Study ]
    Efficacy rate by medical characteristic of patients
  • Previous Medication Factors Affecting the Efficacy Profile [ Time Frame: Baseline and End of Study ]
    Efficacy rate by medical characteristic of patients
  • 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)
  • 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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension
Official Title PMS Study of MicardisPlus Tablet
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
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Hospitals and clinics in Korea
Condition Hypertension
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 22, 2009)
6901
Original Enrollment
 (submitted: April 15, 2008)
7000
Study Completion Date Not Provided
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

patients diagnosed with essential hypertension

Exclusion Criteria:

patients who took Micardis Plus before participating in this PMS study

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00659607
Other Study ID Numbers 502.475
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date May 2014