18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

Completed · Phase 4

Conditions studied: Type 2 Diabetes, Hypertension

In brief

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.

Key facts

Study ID

NCT00654745

Run by

Daiichi Sankyo

People needed

207

Starts

2008-05-01

Expected to finish

2009-06-01

Last updated by the study team

2010-07-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females aged 18 to 80 years.
• Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide);
• Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association criteria, including the specific plasma glucose results listed below:
• Fasting plasma glucose >=126 mg/dL (7.0 mmol/L); or
• Symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose >=200 mg/dL (11.1 mmol/L). The classic symptoms of hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight loss; or
• Two-hour plasma glucose >=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test;
• 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.

You may not qualify if…

• Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).
• Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) >=9.0% at screening;
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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