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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946829
• Other study ID #: 502.425
• Status: Completed
• Start date: January 2003

Study information

• Verified date: July 2009
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18299
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• telmisartan

Locations

Country	Name	City	State
Belgium	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Canada	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Colombia	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Czechia	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Ecuador	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Indonesia	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Jordan	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Lebanon	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Mexico	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Turkey	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Venezuela	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site
Yemen	Boehringer Ingelheim Investigational Site	Boehringer Ingelheim Investigational Site

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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