Study of Hypertensive Population Under Treatment With Telmisartan in Real Clinical Conditions With the Goal to Control Early Morning Blood Pressure Rise
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ClinicalTrials.gov Identifier: NCT00946829 |
Recruitment Status
:
Completed
First Posted
: July 27, 2009
Last Update Posted
: July 27, 2009
|
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Condition or disease | Intervention/treatment |
---|---|
Hypertension | Drug: telmisartan |
Study Type : | Observational |
Actual Enrollment : | 18299 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 Start Date : | January 2003 |
Actual Primary Completion Date : | May 2007 |

- 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). [ Time Frame: 217 Weeks ]
- 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. [ Time Frame: 217 Weeks ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946829
Belgium | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Belgium | |
Canada | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Canada | |
Colombia | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Colombia | |
Czech Republic | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Czech Republic | |
Ecuador | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Ecuador | |
Indonesia | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Indonesia | |
Jordan | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Jordan | |
Lebanon | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Lebanon | |
Mexico | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Mexico | |
Turkey | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Turkey | |
Venezuela | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Venezuela | |
Yemen | |
Boehringer Ingelheim Investigational Site | |
Boehringer Ingelheim Investigational Site, Yemen |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT00946829 History of Changes |
Other Study ID Numbers: |
502.425 |
First Posted: | July 27, 2009 Key Record Dates |
Last Update Posted: | July 27, 2009 |
Last Verified: | July 2009 |
Additional relevant MeSH terms:
Telmisartan Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |