A Study of a Hypertensive Population Under Treatment With... | NCT02242396

Studies
A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® to Control the Early Morning BP Rise (SURGE II)

NCT02242396

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 17, 2014Estimated

Enrollment

5,248Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Telmisartan
Telmisartan hydrochlorothiazide

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

Aug 2005

Primary Completion Date

Nov 2007Actual

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, through the use of Home blood pressure monitoring (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.

The co-primary endpoints were the degree of BP control, and change from baseline until study end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.

Secondary endpoints were office BP control rates, office BP response rates, and reduction in mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit, discontinuations and tolerability

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

5,248Actual

Label	Type	Description	Intervention Names
Hypertensive patients			Drug: Telmisartan Drug: Telmisartan hydrochlorothiazide

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan	Drug		Hypertensive patients	Micardis®
Telmisartan hydrochlorothiazide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of degree of Blood Pressure (BP) control in the early morning hours		8 weeks of treatment
Change from baseline in mSBP and mDBP by HBPM in the early morning	BP control during the morning time-periods (6:00 to 11:59), BP < 135/85 mmHg (HBPM: mean of morning measurements)	Baseline, after 8 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in office BP control rates		Baseline, after 8 weeks
Change from baseline in office BP response rates		Baseline, after 8 weeks
Reduction in mSBP and mDBP by OBPM

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients male or female between 18 and 80 years of age
Patients with mild to moderate essential hypertension
Patients diagnosed with hypertension that are not currently taking antihypertensive medication or previously diagnosed hypertensive patients who are uncontrolled with their current treatment

Exclusion Criteria:

Pre-menopausal women who have no birth control, who are pregnant or nursing
Patients with advanced hepatic impairment or advanced renal impairment
Patients with New York Heart Association (NYHA) functional class III or IV congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
Patients with any type of relevant arrhythmia according to the assessment of the investigator
Patients with any valvular disease with hemodynamic repercussion
Patients receiving chronic administration of oral anticoagulants or digoxin
Patients with known hypersensitivity to any component in the formulation of Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide
Patients with previous history of angioedema associated with angiotensin converting enzyme (ACE) inhibitors
Patients with severe, uncontrolled hypertension or any form of secondary hypertension
Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Hypertensive population under real life clinical practice in an ambulatory setting

Sampling Method

Non-Probability Sample

ID	Term
D006973	Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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

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