Post Marketing Surveillance Study in Rehabilitation Clinics (Cardio, Nephro, Diabetes, Pulmo)

Completed

• Conditions: Hypertension
• Interventions: Drug: Micardis®; Drug: MicardisPlus®

• Registration Number: NCT02262611
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to obtain long-term data on effects, safety and tolerability in routine medical practice and to investigate the potential of telmisartan to prevent secondary organ damage

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2005-12
• Status Verified: 2014-10
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-10
• Last Update Submitted: 2014-10-10
• Study First Posted: 2014-10-13
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

• Adult patients of both gender aged >=18 admitted to a hospital due to insufficiently controlled essential hypertension.

No additional selection criteria have to be considered. Treatment was at the discretion of the physician following the summary of product information for Micardis® and MicardisPlus®

Exclusion Criteria

• not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertension patients - Nephrology	Micardis®	-
Hypertension patients - Nephrology	MicardisPlus®	-
Hypertension patients - Pneumology	Micardis®	-
Hypertension patients - Pneumology	MicardisPlus®	-
Hypertension patients - Cardiology	Micardis®	-
Hypertension patients - Diabetology	Micardis®	-
Hypertension patients - Cardiology	MicardisPlus®	-
Hypertension patients - Diabetology	MicardisPlus®	-

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure	up to 1 year
Number of patients with adverse events	up to 1 year
Number of patients with abnormal changes in laboratory parameters	up to 1 year
Change in diastolic blood pressure	up to 1 year
Number of patients with clinically significant changes in vital signs	up to 1 year

Secondary Outcome Measures

Name	Time	Method
Global assessment of efficacy by investigator on a 4-point scale	2 weeks, after 1 year
Global assessment of tolerability by investigator on a 4-point scale	2 weeks, after 1 year