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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02176850
• Collaborator: (none)
• Enrollment: 19,870

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Micardis®

Study Design

• Study Type: Observational
• Actual Enrollment: 19870 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Safety, Tolerability and Efficacy of Micardis® (Telmisartan) in Patients With Essential Hypertension
• Study Start Date: Jan 1, 1999
• Actual Primary Completion Date: May 1, 2000

Arms and Interventions

Arm	Intervention/Treatment
Micardis®	Drug: Micardis®

Outcome Measures

Primary Outcome Measures

1. Indicence of ulcera [Up to 6 months after start of study]

2. Incidence of gastrointestinal (GI) bleedings [Up to 6 months after start of study]

Secondary Outcome Measures

1. Incidence of adverse events (GI-complaints inclusive) [Up to 6 months after start of study]

2. Change from baseline in office blood pressure [Up to 6 months after start of study]

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria: (Not applicable)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02176850
• Other Study ID Numbers: 502.314
• First Posted: Jun 27, 2014
• Last Update Posted: Jul 8, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Telmisartan

Study Results

No Results Posted as of Jul 8, 2014