Telmisartan Fixed-Dose Combination Versus Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus

This study is currently recruiting participants.

Verified by Boehringer Ingelheim Pharmaceuticals, April 2009

First Received: February 6, 2009 Last Updated: April 7, 2009 History of Changes

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00877929

Purpose

The purpose of this study is to demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.

Condition	Intervention	Phase
Hypertension	Drug: telmisartan Drug: amlodipine	Phase III

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Telmisartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 8-Week Randomised, Double-Blind Study to Compare the Fixed-Dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Type 2 Diabetes Patients With Hypertension.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary endpoint is the change from baseline in the mean seated trough cuff SBP following eight weeks of treatment. [ Time Frame: eight weeks of treatment ]

Secondary Outcome Measures:

Change from baseline in SBP following 1,2, 4 and 6 weeks of treatment. Change from baseline in DBP and BP response variables after 1,2,4,6 and 8 weeks of treatment. Safety endpoints will also be assessed. [ Time Frame: eight weeks of treatment ]

Estimated Enrollment:	402
Study Start Date:	February 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients =>18 years of age with type 2 diabetes mellitus and Stage 1or 2 hypertension (defined as SBP>150 mmHg)

Exclusion Criteria:

pregnant, breast-feeding or unwilling to use approved birth control during the study
type 1 diabetes; HbA1c >10%
secondary hypertension; renal dysfunction
hepatic insufficiency
stroke with-in the past six months
myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months
history of angioedema or hypersensitibity to either study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877929

Contacts

Contact: Boehringer Ingelheim Study Coordinator

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Show 50 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1235.21
Study First Received:	February 6, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00877929 History of Changes
Health Authority:	Korea: Food and Drug Administration; Mexico: Federal Commission for Sanitary Risks Protection; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Spain: Comité Ético de Investigación Clínica; Spain: Ethics Committee; United States: Food and Drug Administration

Study placed in the following topic categories:

Vasodilator Agents
Metabolic Diseases
Diabetes Mellitus
Vascular Diseases
Calcium Channel Blockers
Endocrine System Diseases
Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Protease Inhibitors

Amlodipine
Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Diabetes Mellitus, Type 2
Angiotensin-Converting Enzyme Inhibitors
Endocrinopathy
Telmisartan
Glucose Metabolism Disorders
Metabolic Disorder
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus
Vascular Diseases
Calcium Channel Blockers
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Therapeutic Uses
Diabetes Mellitus, Type 2
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009