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

NCT ID: NCT00654745

Last Updated: 2010-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-06-30

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.

Conditions

Type 2 Diabetes; Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aml + olm + hctz

amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.

Group Type: EXPERIMENTAL

Amlodipine

Intervention Type: DRUG

Amlodipine 5 mg tablets , Daily for 3 weeks;

amlodipine / olmesartan medoxomil combination

Intervention Type: DRUG

amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg

Hydrochlorothiazide

Intervention Type: DRUG

hydrochlorothiazide tablets, 12.5 mg or 25 mg.

Interventions

Amlodipine

Amlodipine 5 mg tablets , Daily for 3 weeks;

Intervention Type: DRUG

amlodipine / olmesartan medoxomil combination

amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg

Intervention Type: DRUG

Hydrochlorothiazide

hydrochlorothiazide tablets, 12.5 mg or 25 mg.

Intervention Type: DRUG

Other Intervention Names

Norvasc; Azor

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Daiichi Sankyo Inc.

Locations

Los Angeles, California, United States

Sylmar, California, United States

Tustin, California, United States

Aventura, Florida, United States

DeLand, Florida, United States

Hialeah, Florida, United States

Pembroke Pines, Florida, United States

Avon, Indiana, United States

Indianapolis, Indiana, United States

Las Vegas, Nevada, United States

New Windsor, New York, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Charleston, South Carolina, United States

Greer, South Carolina, United States

Taylors, South Carolina, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Burke, Virginia, United States

Countries

United States

Other Identifiers

CS-8663-403

Identifier Type: -

Identifier Source: org_study_id