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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Telmisartan; Drug: Telmisartan hydrochlorothiazide

• Study Type: Observational
• Enrollment (Actual): 5248

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hypertensive population under real life clinical practice in an ambulatory setting

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypertensive patients	Drug: Telmisartan; Other Names: Micardis®; Drug: Telmisartan hydrochlorothiazide; Other Names: Micardis Plus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	up to 8 weeks
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	Baseline, after 8 weeks
Global Assessment of tolerability by investigator on a 6-point scale	after 8 weeks
Global assessment efficacy by investigator on 6-point scale	after 8 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 17, 2014

Study Record Updates

• Last Update Posted (Estimate): September 17, 2014
• Last Update Submitted That Met QC Criteria: September 16, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Telmisartan; Telmisartan, hydrochlorothiazide drug combination
• Other Study ID Numbers: 502.496