TElmisartan 80 mg plus AMlodipine 10 mg fixed-dose combination tablet STudy versus Amlodipine 10 mg over-encapsulated tablets as first line therapy inpatients with Type 2 Diabetes Mellitus and Stage I or II hypertension: a Phase III, eight week, randomised, double-blind, double-dummy, forced titration compariso

Phase 1

• Conditions: Hypertension; MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2008-000874-19-SK
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG C

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-12
• Last Update Posted: 13 March 2017

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 dysfunction 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