Safety, Tolerability and Efficacy of Micardis® in Patients With Essential Hypertension

Completed

• Conditions: Hypertension
• Interventions: Drug: Micardis®

• Registration Number: NCT02176850
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy of Micardis® collected during the clinical studies.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2000-05
• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19870

Inclusion Criteria

• Patients of both sexes with essential hypertension and a minimum age of 18 years

Exclusion Criteria

(Not applicable)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Micardis®	Micardis®	-

Primary Outcome Measures

Name	Time	Method
Indicence of ulcera	Up to 6 months after start of study
Incidence of gastrointestinal (GI) bleedings	Up to 6 months after start of study

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (GI-complaints inclusive)	Up to 6 months after start of study
Change from baseline in office blood pressure	Up to 6 months after start of study
Response rate	Up to 6 months after start of study	full response: reduction of diastolic blood pressure (DBP) by \>= 10 mmHg or final DBP \<= 90 mmHg overall response: reduction of DBP by \>= 7mmHg or final DBP \<= 90 mmHg