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Sponsors and Collaborators: |
Daiichi Sankyo Inc. Integrium |
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Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00791258 |
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.
Condition | Intervention | Phase |
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Hypertension |
Drug: amlodipine and olmesartan medoxomil tablets Drug: hydrochlorothiazide tablets |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy |
Estimated Enrollment: | 900 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks
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Drug: amlodipine and olmesartan medoxomil tablets
amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks
Drug: hydrochlorothiazide tablets
hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Julie B Tobin | 623-271-9334 | julie.tobin@integrium.com |
Responsible Party: | Daiichi Sankyo ( Diector of Medical Research and Strategy ) |
Study ID Numbers: | CS8663-404 |
Study First Received: | November 13, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00791258 |
Health Authority: | United States: Food and Drug Administration |
Calcium, Dietary Vascular Diseases Olmesartan medoxomil Angiotensin II |
Hydrochlorothiazide Amlodipine Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Calcium Channel Blockers Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases |