Study of Hypertensive Population Under Treatment With Telmisartan in Real Clinical Conditions With the Goal to Control Early Morning Blood Pressure Rise

Completed

• Conditions: Hypertension

• Registration Number: NCT00946829
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2007-05
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18299

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	217 Weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇾🇪 Boehringer Ingelheim Investigational Site, Yemen