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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Placebo tablets for 2 to 3 weeks
• 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;

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Placebo run-in
• Experimental: 2
  • amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required

Primary Measures

• Change from baseline in mean 24-hour ABPM SBP after 12 weeks of active treatment
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Change from baseline in mean 24-hour ABPM DBP after 12 weeks of active treatment
  • Time Frame: 12 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Daiichi Sankyo Inc.

Overall Clinical Trial Officials and Contacts

Overall Contact: Doug Logan, MD 513.579.9911 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00654745

Study ID Number: CS-8663-403

ClinicalTrials.gov Identifier: NCT00654745

Health Authority: United States: Food and Drug Administration