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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00946829

Enrollment

18299

Registered

2009-07-27

Start date

2003-01-31

Completion date

Unknown

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DRUGtelmisartan

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Belgium, Canada, Colombia, Czechia, Ecuador, Indonesia, Jordan, Lebanon, Mexico, Turkey (Türkiye), Venezuela, Yemen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026