Study to Evaluate the Effect of the Treatment With Micard... | NCT02242864

Studies
Study to Evaluate the Effect of the Treatment With Micardis® or MicardisPlus® on Blood Pressure

NCT02242864

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 17, 2014Estimated

Enrollment

1,527Actual

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

Status Module

Record Verification Date

Sep 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 2006

Primary Completion Date

Oct 2006Actual

Completion Date

Not provided

First Submitted Date

Sep 16, 2014

First Submission Date that Met QC Criteria

Sep 16, 2014

First Posted Date

Sep 17, 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

Sep 16, 2014

Last Update Posted Date

Sep 17, 2014Estimated

Description Module

Brief Summary

The primary objective was to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives were the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, LDL blood glucose, insulin Homeostasis Model Assessment (HOMA)-index and HbA1c) in patients with essential hypertension and diabetes mellitus

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

1,527Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with hypertension and diabetes mellitus			Drug: Micardis® Drug: MicardisPlus®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Micardis®	Drug		Patients with hypertension and diabetes mellitus
MicardisPlus®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in systolic blood pressure (SBP)		Baseline, after 6 months
Change from Baseline in diastolic blood pressure (DBP)		Baseline, after 6 months

Secondary Outcomes

Measure	Description	Time Frame
Assessment of efficacy by investigator on a 6-point scale		after 6 months
Assessment of metabolic effect on a 3-point scale		after 6 months
Change from Baseline in laboratory parameters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Hypertension
Diabetes mellitus

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 and diabetes mellitus

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