Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

Completed

• Conditions: Hypertension

• Registration Number: NCT00659607
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2008-04-10
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-16
• Primary Completion: 2008-07
• Results First Submitted: 2009-07-29
• Results First Submitted QC: 2009-09-22
• Results First Posted: 2009-10-22
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6901

Inclusion Criteria

patients diagnosed with essential hypertension

Exclusion Criteria

patients who took Micardis Plus before participating in this PMS study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Unexpected Adverse Events	Up to 6 years	Occurrence status of unexpected adverse events
Frequency of Adverse Events	Up to 6 years
Change From Baseline in SBP (Systolic Blood Pressure) at Week 2	Baseline and End of Study	Effect on decrease in systolic blood pressure
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2	Baseline and End of Study	Effect on decrease in diastolic blood pressure
Effective Rate	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

Name	Time	Method
Gender Factors Affecting the Safety Profile	Up to 6 years	Occurrence status of adverse events by Gender category of patients
Age Factors Affecting the Safety Profile	Up to 6 years	Occurrence status of adverse events by Age category of patients
Proportion of Geriatric Population Factor Affecting the Safety Profile	Up to 6 years	Occurrence status of adverse events by Proportion of geriatric population of patients
Treatment Type Factors Affecting the Safety Profile	Up to 6 years	Occurrence status of adverse events by Treatment type of patients
Medical History Factors Affecting the Safety Profile	Up to 6 years	Occurrence status of adverse events by medical history of patients
Concomitant Disease Factors Affecting the Safety Profile	Up to 6 years	Occurrence status of adverse events by Concomitant disease of patients
Medical History Factors Affecting the Efficacy Profile	Baseline and End of Study	Efficacy rate by medical characteristic of patients
Previous Medication Factors Affecting the Efficacy Profile	Baseline and End of Study	Efficacy rate by medical characteristic of patients
Baseline Severity of Hypertension Factors Affecting the Efficacy Profile	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	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

Trial Locations

Locations (74)

Boehringer Ingelheim Investigational Site 10; 🇰🇷 Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site 11; 🇰🇷 Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site 12; 🇰🇷 Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site 13; 🇰🇷 Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site 14; 🇰🇷 Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site 15; 🇰🇷 Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site 16; 🇰🇷 Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site 17; 🇰🇷 Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site 18; 🇰🇷 Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site 19; 🇰🇷 Seoul, Korea, Republic of

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