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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

18,299

participants targeted

Target at P75+ for all trials

Geographic Reach

12 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed

2.2 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed

Last Updated

November 5, 2019

Status Verified

July 1, 2009

Enrollment Period

4.3 years

First QC Date

July 24, 2009

Last Update Submit

November 4, 2019

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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

Interventions

telmisartanDRUG

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.