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Sponsored by: |
Daiichi Sankyo Europe, GmbH |
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Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00751829 |
To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.
Condition | Intervention | Phase |
---|---|---|
Isolated Systolic Hypertension |
Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary Drug: nitrendipine + hydrochlorothiazide, if necessary |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension |
Enrollment: | 417 |
Study Start Date: | July 2003 |
Study Completion Date: | February 2005 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to controll BP
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Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
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2: Active Comparator
oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
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Drug: nitrendipine + hydrochlorothiazide, if necessary
oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
|
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Daiichi Sankyo Europe, GmbH ( Petra Laeis, Ph.D. ) |
Study ID Numbers: | SE-866/37 |
Study First Received: | September 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751829 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Vasodilator Agents Nitrendipine Diuretics Sodium Chloride Symporter Inhibitors Vascular Diseases Calcium Channel Blockers Olmesartan medoxomil |
Cardiovascular Agents Angiotensin II Antihypertensive Agents Hydrochlorothiazide Angiotensin II Type 1 Receptor Blockers Calcium, Dietary Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Nitrendipine Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Calcium Channel Blockers Olmesartan medoxomil Cardiovascular Agents |
Antihypertensive Agents Hydrochlorothiazide Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Hypertension |