Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT00946829 |
Date of registration:
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24/07/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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Study of Hypertensive Population Under Treatment With Micardis in Real Clinical Conditions With the Goal to Control the Early Morning BP Rise |
Date of first enrolment:
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January 2003 |
Target sample size:
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18299 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00946829 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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Belgium
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Canada
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Colombia
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Czech Republic
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Czechia
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Ecuador
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Indonesia
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Jordan
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Lebanon
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Mexico
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Turkey
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Venezuela
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Yemen
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Contacts
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Name:
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Boehringer Ingelheim |
Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: telmisartan
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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