Study of Hypertensive Population Under Treatment With Micardis in Real Clinical Conditions With the Goal to Control the Early Morning BP Rise

Boehringer Ingelheim1 site in 1 country18,299 target enrollmentJanuary 2003

ConditionsHypertension

Drugstelmisartan

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Enrollment: 18299
Locations: 1
Primary Endpoint: Change from baseline in mean early morning systolic blood pressure, mean early morning diastolic blood pressure, and degree of control. (6:00 to 11:59), BP < 135/85 mmHg. (HBPM: mean of morning measurements).
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the observational study is to ascertain the degree of blood pressure control in the early-morning hours after 8 weeks of treatment with Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients with hypertension using home blood pressure measurements.

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

May 2007

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

•Patients with mild to moderate essential hypertension and whose medical condition make them eligible for treatment with Telmisartan/Telmisartan+HCTZ

Exclusion Criteria

•Pre-menopausal women who had had no birth control, who are pregnant or nursing
•Patients with advanced hepatic impairment, advanced renal impairment or both
•Patients with functional class III or IV (NYHA) congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
•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 / MicardisPlus
•Patients with previous history of angioedema associated with 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

Outcomes

Primary Outcomes

Change from baseline in mean early morning systolic blood pressure, mean early morning diastolic blood pressure, and degree of control. (6:00 to 11:59), BP < 135/85 mmHg. (HBPM: mean of morning measurements).

Time Frame: 217 Weeks

Secondary Outcomes

Clinical control (office BP), response rates, reduction in office cuff systolic and diastolic BP. Office BP control criteria: BP < 140/90 mmHg. Pulse rate, pulse pressure, discontinuations and tolerability.(217 Weeks)