N/A N=3,932

Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00659607 ↗

Enrolled (actual)

3,932

Serious AEs

0.0%

Results posted

Oct 2009

Primary outcome: Primary: Unexpected Adverse Events — 0.58 Percentage of patients

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Unexpected Adverse Events	0.58	—
PRIMARY Frequency of Adverse Events	1.04	—
PRIMARY Change From Baseline in SBP (Systolic Blood Pressure) at Week 2	-29	<0.0001 sig
PRIMARY Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2	-15	<0.0001 sig
PRIMARY Effective Rate	99	—
SECONDARY Gender Factors Affecting the Safety Profile	1.24; 0.88	0.2669
SECONDARY Age Factors Affecting the Safety Profile	0; 1.32; 1.20; 1.13; 0.88; 1.04	0.9674
SECONDARY Proportion of Geriatric Population Factor Affecting the Safety Profile	1.03; 1.07	0.9207
SECONDARY Treatment Type Factors Affecting the Safety Profile	0; 1.10; 1.40	0.8249
SECONDARY Medical History Factors Affecting the Safety Profile	1.97; 0.68	0.0003 sig
SECONDARY Concomitant Disease Factors Affecting the Safety Profile	2.30; 0.56	<0.0001 sig
SECONDARY Medical History Factors Affecting the Efficacy Profile	98.1; 99.2	0.0075 sig
SECONDARY Previous Medication Factors Affecting the Efficacy Profile	98.3; 99.6	0.0007 sig
SECONDARY Baseline Severity of Hypertension Factors Affecting the Efficacy Profile	98.3; 99.2; 98.3	0.0393 sig
SECONDARY Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile	98.8; 95.8; 99.4	0.0245 sig

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

Eligibility Criteria

Inclusion Criteria

patients diagnosed with essential hypertension

Exclusion Criteria

patients who took Micardis Plus before participating in this PMS study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00659607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.