TElmisartan 80 mg plus AMlodipine 10 mg fixed-dose combination tablet STudy versus Amlodipine 10 mg over encapsulated tablets as first line therapy in patients with Type 2 Diabetes Mellitus and Stage 1 or 2 hypertension: a phase III, eight week, randomised, double-blind, double-dummy, forced titration comparison - a ABPM substudy
Phase 3
Recruiting
- Conditions
- cardiovasculair, hypertensiehigh blood pressurehypertension
- Registration Number
- NL-OMON33529
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 78
Inclusion Criteria
Baseline mean seated systolic blood pressure >150 mmHg; diagnosis of type 2 diabetes mellitus; age = >18; ability to stop current antihypertensive therapy without unacceptable risk to the patient and ability to provide written informed consent.
Exclusion Criteria
Pre-menopausal women who are not pregnant, nursing, surgically sterile or practicing approved birth control; night shift workers; mean seated systolic =>180 and/or diastolic >=120 mmHg; type 1 diabetes mellitus; renal dysfunttion defined by laboratory parameters; functional class III-IV CHF; sensitivity to study drugs; concomitant medication known to affect blood pressure and unstable diabetes defined by HbA1c >10%
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>the change from baseline in the mean seated trough cuff SBP following eight<br /><br>weeks of treatment</p><br>
- Secondary Outcome Measures
Name Time Method