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18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics | Clinical Trials | Clareo Health

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

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

NCT00654745•Daiichi Sankyo

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (21)

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

Key Dates

Start Date

May 1, 2008

Primary Completion Date

April 1, 2009

Completion Date

June 1, 2009

Last Updated

July 13, 2010

Enrollment

207

ACTUAL participants

Conditions

Type 2 DiabetesHypertension

Interventions

Amlodipine

DRUG

amlodipine / olmesartan medoxomil combination

DRUG

Hydrochlorothiazide

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

Feasibility of a Tailored Online Self-compassion Intervention

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