A Phase III, eight week randomised double-blind, double-dummy,forced titration study to compare the fixed-dose combination tablet oftelmisartan 80 mg plus amlodipine 10 mg versus amlodipine 10 mgover encapsulated capsules mono-therapy as first line therapy inpatients with type 2 diabetes mellitus and Stage I or II hypertension - TEAMSTAT2DM

• Conditions: type 2 diabetes and mild to moderate hypertension; MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2008-000874-19-NL
• Lead Sponsor: Boehringer Ingelheim Pharmaceuticals. Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To assess changes from baseline in diastolic blood pressure and blood pressure control variables. As well, safety will be assessed. ;Primary end point(s): The change from baseline in the mean seated trough cuff systolic blood pressure after eight weeks of treatment.;Main Objective: To demonstrate that the fixed-dose combination of telmisartan 80 mg plus amlodipine 10 mg is superior as first line therapy in reducing mean seated trough cuff systolic blood presure compared to the monotherapy of amlodipine 10 mg in patients with type 2 diabetes and Stage I or II hypertension.