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

NCT ID: NCT02242396

Last Updated: 2014-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5248 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-08-31

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

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hypertensive patients

Telmisartan

Intervention Type: DRUG

Telmisartan hydrochlorothiazide

Intervention Type: DRUG

Interventions

Telmisartan

Intervention Type: DRUG

Telmisartan hydrochlorothiazide

Intervention Type: DRUG

Other Intervention Names

Micardis®; Micardis Plus®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

502.496

Identifier Type: -

Identifier Source: org_study_id