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| Trial Identifiers: |
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| Identifier |
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Owner |
| 1235-1 |
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Boehringer Ingelheim |
| 700015787 |
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Clinical Trials Insight |
| NCT00281580 |
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ClinicalTrials.gov: US National Institutes of Health |
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ClinicalTrials.gov: US National Institutes of Health. Trial Registry: 2006. Available from: URL: http://clinicaltrials.gov USA |
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| Actual Initiation Date: |
01/04/2006 |
| Planned End Date: |
01/12/2007 |
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| Design: |
Double-blind, multicentre, randomised |
| Control: |
Baseline comparison, drug dosage comparison |
| Status: |
Completed |
| Phase: |
III |
| Location: |
Argentina, Brazil, Mexico, Multinational, South Africa, USA |
| Endpoints: |
Clinical response rate, Diastolic blood pressure, Systolic blood pressure |
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| Type |
No. of Patients |
Age |
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| patients |
1461 (Planned) |
adult |
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| Patient Inclusion Criteria: Male or female patients at least 18 years of age, stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure greater than or equal to 95 and less than or equal to 119mm Hg. |
| Patient Exclusion Criteria: Pregnant, breast-feeding, unwilling to use birth control during the study, secondary hypertension, systolic blood pressure greater than or equal to 180mm Hg, diastolic blood pressure greater than or equal to 120mm Hg, severe renal dysfunction, hepatic insufficiency, stroke within the last 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months, unstable or uncontrolled diabetes, history of angioedema of either of the study drugs, hypersensitivity to the study drugs. |
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| This trial is entitled "A randomized, double-blind, double-dummy, placebo-controlled, 4x4 factorial design trial to evaluate telmisartan 20, 40 and 80 mg tablets in combination with amlodipine 2.5, 5 and 10 mg capsules after eight weeks of treatment in patients with stage I or II hypertension, with an ABPM sub-study". The primary endpoint will be the change in seated trough cuff diastolic blood pressure at 8 weeks. |
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| Showing 10 of 119 total Study Centres. |
Study Centre
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City
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Country
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Investigators |
Contact Details |
Boehringer Ingelheim |
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E-mail: clintriage@rdg.boehringer-ingelheim.com
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Cordoba |
Argentina |
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Buenos Aires |
Argentina |
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Villa Carlos Paz |
Argentina |
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Belo Horizonte |
Brazil |
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Recife |
Brazil |
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Maceio |
Brazil |
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Vitoria |
Brazil |
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Botucatu |
Brazil |
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Mexico |
Mexico |
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 Show remaining 109 Study Centres...
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 Lead Study Centre / Investigator. |
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| Date |
Update Type |
Comment |
| 07 Oct 2006 |
New trial record |
New trial record. |
| 14 Nov 2007 |
Completion date |
The expected completion date for this trial is now 1 Dec 2007. |
| 06 Mar 2008 |
Status change - completed |
Status changed from recruiting to completed. |
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Amlodipine: therapeutic use
Hypertension: treatment
Telmisartan: therapeutic use |
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