Micardis® / MicardisPlus® Program for Therapy Optimizatio... | NCT02262637

Studies
Micardis® / MicardisPlus® Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases (PROTEKT)

NCT02262637

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Oct 13, 2014Estimated

Enrollment

4,814Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Micardis®
MicardisPlus®

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

ID	Type	Description	Link
502.442, 502.443	Other Identifier	Boehringer Ingelheim

Status Module

Record Verification Date

Oct 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

Sep 2003

Primary Completion Date

Mar 2006Actual

Completion Date

Not provided

First Submitted Date

Oct 10, 2014

First Submission Date that Met QC Criteria

Oct 10, 2014

First Posted Date

Oct 13, 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

Oct 10, 2014

Last Update Posted Date

Oct 13, 2014Estimated

Description Module

Brief Summary

Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the clientele of cardiologists, nephrologists, and diabetologists

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

4,814Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypertensive patients - Cardiologists			Drug: Micardis® Drug: MicardisPlus®
Hypertensive patients - Nephrologists			Drug: Micardis® Drug: MicardisPlus®
Hypertensive patients - Diabetologists			Drug: Micardis® Drug: MicardisPlus®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Micardis®	Drug		Hypertensive patients - Cardiologists Hypertensive patients - Diabetologists Hypertensive patients - Nephrologists

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in systolic blood pressure (SBP)		baseline, up to 6 months
Change in diastolic blood pressure (DBP)		baseline, up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >= 18 years

Exclusion Criteria:

Age < 18 years

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

Outpatients with hypertension recruited at Cardiologists, Nephrologists, Diabetologists

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
C436283	telmisartan, hydrochlorothiazide drug combination

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided