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

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan; Drug: Telmisartan hydrochlorothiazide

• Registration Number: NCT02242396
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2007-11
• Status Verified: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Last Update Submitted: 2014-09-16
• Study First Posted: 2014-09-17
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5248

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertensive patients	Telmisartan	-
Hypertensive patients	Telmisartan hydrochlorothiazide	-

Primary Outcome Measures

Name	Time	Method
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	Baseline, after 8 weeks of treatment	BP control during the morning time-periods (6:00 to 11:59), BP \< 135/85 mmHg (HBPM: mean of morning measurements)

Secondary Outcome Measures

Name	Time	Method
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
Number of patients with adverse events	up to 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