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  1   Telmisartan + amlodipine: therapeutic use
Phase III trial (700015787)

Telmisartan + amlodipine: therapeutic use
Phase III trial
Ongoing Trial
Last Modified: 10/03/2008
Protocol / Study ID
Trial Identifiers:
Identifier Owner
1235-1 Boehringer Ingelheim
700015787 Clinical Trials Insight
NCT00281580 ClinicalTrials.gov: US National Institutes of Health
Data Sources
ClinicalTrials.gov: US National Institutes of Health. Trial Registry: 2006. Available from: URL: http://clinicaltrials.gov USA
Study Details
Study Dates
Actual Initiation Date: 01/04/2006
Planned End Date: 01/12/2007
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
Type No. of Patients Age
patients 1461 (Planned) adult

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.
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.
Study Centres
  Showing 10 of 119 total Study Centres.
Study Centre City Country Investigators Contact Details
Boehringer Ingelheim   E-mail: clintriage@rdg.boehringer-ingelheim.com

Cordoba Argentina    
Buenos Aires Argentina    
Villa Carlos Paz Argentina    
Belo Horizonte Brazil    
Recife Brazil    
Maceio Brazil    
Vitoria Brazil    
Botucatu Brazil    
Mexico Mexico    
   Show remaining 109 Study Centres...
   Lead Study Centre / Investigator.
Study History
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.
Descriptors & Links
Adis Descriptors
Amlodipine: therapeutic use
Hypertension: treatment
Telmisartan: therapeutic use
Boehringer Ingelheim
Related Documents
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R&D Insight Profile Telmisartan
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