Post-marketing Study to Supplement Data on Safety, Tolerability and Efficacy of Micardis® With Special Emphasis on the Control of Blood Pressure

Completed

• Conditions: Hypertension
• Interventions: Drug: Micardis®

• Registration Number: NCT02242331
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This post-marketing surveillance study is designed to supplement under conditions of normal clinical practice data on safety, tolerability and efficacy of Micardis® collected in clinical studies with special emphasis on the control of blood pressure in the morning before intake of the next antihypertensive drug

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2002-05
• Status Verified: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Last Update Submitted: 2014-09-16
• Study First Posted: 2014-09-17
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19805

Inclusion Criteria

• Essential hypertension
• At least 18 years of age

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Exclusion Criteria

• NA

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
essential hypertension patients	Micardis®	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in blood pressure	Baseline, after 3 months	with special emphasis on the morning blood pressure, before intake of the next antihypertensive treatment
Changes from baseline in pulse rate	Baseline, after 3 months
Number of patients with adverse events	up to 3 months

Secondary Outcome Measures

Name	Time	Method
Assessment of efficacy by investigator on 5- point scale	after 3 months
Assessment of tolerability by investigator on a 5-point scale	after 3 months