Study to Evaluate After 18 Weeks of Treatment, the Safety and Effectiveness of Combined Treatment With Olmesartan Medoxomil and Amlodipine Alone, and With Hydrocholorothiazide, to Reduce High Blood Pressure in Type 2 Diabetic Subjects

This study is currently recruiting participants.

Verified by Daiichi Sankyo Inc., July 2008

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00654745

Purpose

To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

Condition	Intervention	Phase
Type 2 Diabetes Hypertension	Drug: Placebo Drug: Amlodipine, Amlodipine/Olmesartan combination, and HCTZ	Phase IV

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Open-Label, Ambulatory Blood Pressure Monitoring (ABPM) Dose Titration Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil and Amlodipine Based Treatment Regimen in Hypertensive, Type 2 Diabetic Subjects

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Change from baseline in mean 24-hour ABPM SBP after 12 weeks of active treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in mean 24-hour ABPM DBP after 12 weeks of active treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Placebo run-in	Drug: Placebo Placebo tablets for 2 to 3 weeks
2: Experimental amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required	Drug: Amlodipine, Amlodipine/Olmesartan combination, and HCTZ Amlodipine tablets , Daily for 3 weeks; if required, Amlodipine + Olmesartan tablets, daily for at least 3 weeks; if required, Amlodipine + Olmesartan tablets + HCTZ tablets, daily for at least 3 weeks;

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females aged 18 to 80 years.
Controlled type 2, non-insulin dependent diabetic subjects.
Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP >130 mmHg and/or DBP >80 mmHg) on current antihypertensive monotherapy or combination therapy.
Subjects must fulfill mean seated office blood pressure parameters at two consecutive, qualifying visits during the placebo run-in phase, and, subsequently, daytime ambulatory blood pressure monitoring (ABPM) criteria.
Females should not be pregnant or lactating and, if applicable, using adequate contraception.

Exclusion Criteria:

Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).
Subjects with uncontrolled type 2 diabetes mellitus.
Subjects with type 1 or type 2 diabetes mellitus requiring insulin.
Subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary hypertension.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654745

Contacts

Contact: Doug Logan, MD	513.579.9911
Contact: Dan Smoker, BS

Locations

United States, California
	Recruiting
Los Angeles, California, United States
	Recruiting
Tustin, California, United States
United States, Florida
	Recruiting
Hialeah, Florida, United States
	Recruiting
Pembroke Pines, Florida, United States
	Recruiting
DeLand, Florida, United States
United States, Indiana
	Recruiting
Avon, Indiana, United States
	Recruiting
Indianapolis, Indiana, United States
United States, Nevada
	Recruiting
Las Vegas, Nevada, United States
United States, New York
	Recruiting
New Windsor, New York, United States
United States, North Carolina
	Recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
	Recruiting
Cincinnati, Ohio, United States
United States, Oklahoma
	Recruiting
Oklahoma City, Oklahoma, United States
United States, South Carolina
	Recruiting
Greer, South Carolina, United States
	Recruiting
Taylors, South Carolina, United States
	Recruiting
Charleston, South Carolina, United States
United States, Tennessee
	Recruiting
Nashville, Tennessee, United States
United States, Texas
	Recruiting
San Antonio, Texas, United States
United States, Virginia
	Recruiting
Burke, Virginia, United States

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

Responsible Party:	Daiichi Sankyo Inc. ( Director, Medical Research, Hypertension )
Study ID Numbers:	CS-8663-403
Study First Received:	April 4, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00654745
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

blood pressure reduction

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Olmesartan medoxomil
Angiotensin II
Amlodipine

Calcium, Dietary
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Calcium Channel Blockers
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009