Clinical trial NCT00946829: Study of Hypertensive Population Under Treatment With Telmisartan in Real Clinical Conditions With the Goal to Control Early Morning Blood Pressure Rise
Official title: Study of Hypertensive Population Under Treatment With Micardis in Real Clinical Conditions With the Goal to Control the Early Morning BP Rise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 18299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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.


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

Primary outcomes:
measure: 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).
timeFrame: 217 Weeks
Secondary outcomes:
measure: 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.
timeFrame: 217 Weeks
Other outcomes:
Locations:
city: Boehringer Ingelheim Investigational Site
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Canada
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Czechia
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Ecuador
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Indonesia
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Jordan
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Lebanon
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Mexico
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Turkey
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Venezuela
facility: Boehringer Ingelheim Investigational Site
city: Boehringer Ingelheim Investigational Site
country: Yemen
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: