Post-Marketing Surveillance Study of Micardis® Plus in Patients With Hypertension

Completed

• Conditions: Hypertension
• Interventions: Drug: Micardis® plus

• Registration Number: NCT02238275
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to evaluate efficacy and tolerability of Micardis® plus under usual daily-practice prescribing-conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2002-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-11
• Last Update Submitted: 2014-09-11
• Study First Posted: 2014-09-12
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8135

Inclusion Criteria

• Adult (Age >= 18 years) males and females for whom a medical antihypertensive therapy is indicated

Exclusion Criteria

• Age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with hypertension	Micardis® plus	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in morning blood pressure	Baseline, after 6 weeks
Change from baseline in classification of blood pressure	Baseline, after 6 weeks	according to Word Health Organisation - Isolated systolic hypertension (WHO-ISH) - definition of 'Deutsche Hochdruckliga'

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse drug reactions	up to 6 weeks
Assessment of efficacy by investigator on 5-point scale	after 6 weeks
Assessment of tolerability by investigator on a 5-point scale	after 6 weeks
Change from baseline in heart rate	Baseline, after 6 weeks