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Study of Hypertensive Population Under Treatment With Telmisartan in Real Clinical Conditions With the Goal to Control Early Morning Blood Pressure Rise
This study has been completed.
Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00946829
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
| Hypertension | Drug: telmisartan |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 18299 |
| Study Start Date: | January 2003 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Eligibility| 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 |
Study Population
Primary Care Clinic
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00946829
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946829
Locations
| 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 | |
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00946829 History of Changes |
| Other Study ID Numbers: |
502.425 |
| Study First Received: | July 24, 2009 |
| Last Updated: | July 24, 2009 |
Additional relevant MeSH terms:
|
Telmisartan Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 21, 2017