Safety, Tolerability and Efficacy of Micardis® in Patient... | NCT02176850

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

NCT02176850

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 8, 2014Estimated

Enrollment

19,870Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Micardis®

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

May 2000Actual

Completion Date

Not provided

First Submitted Date

Jun 25, 2014

First Submission Date that Met QC Criteria

Jun 26, 2014

First Posted Date

Jun 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2014

Last Update Posted Date

Jul 8, 2014Estimated

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19,870Actual

Label	Type	Description	Intervention Names
Micardis®			Drug: Micardis®

Name	Type	Description	Arm Group Labels	Other Names
Micardis®	Drug		Micardis®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria: (Not applicable)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients of general practioners, cardiologists and specialist in internal medicine in non-hospital practice

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077333	Telmisartan

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided