Status:
COMPLETED
18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
Lead Sponsor:
Daiichi Sankyo
Conditions:
Type 2 Diabetes
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00654745
Start Date
May 1 2008
End Date
June 1 2009
Last Update
July 13 2010
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Angeles, California, United States
2
Sylmar, California, United States
3
Tustin, California, United States
4
Aventura, Florida, United States