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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00696241 |
The purpose of this study is to determine the safety and efficacy of TAK-491 compared to olmesartan in subjects with essential hypertension.
Condition | Intervention | Phase |
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Essential Hypertension |
Drug: TAK-491 and olmesartan Drug: TAK-491 & olmesartan Drug: Olmesartan Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Subjects With Essential Hypertension |
Enrollment: | 1275 |
Study Start Date: | June 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: TAK-491 and olmesartan
TAK-491 20 mg, tablets, TAK-491 40 mg placebo-matching tablets, TAK-491 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching capsules, orally, for up to 6 weeks.
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2: Experimental |
Drug: TAK-491 and olmesartan
TAK-491 40 mg, tablets, TAK-491 20 mg placebo-matching tablets, TAK-491 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching capsules, orally, for up to 6 weeks.
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3: Experimental |
Drug: TAK-491 & olmesartan
TAK-491 80 mg, tablets, TAK-491 20 mg placebo-matching tablets, TAK-491 40 mg placebo-matching tablets and olmesartan 40 mg placebo-matching capsules, orally, once daily for up to 6 weeks.
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4: Active Comparator |
Drug: Olmesartan
Olmesartan 40 mg, capsules, TAK-491 20 mg placebo-matching tablets, TAK-491 40 mg placebo-matching tablets and TAK-491 80 mg placebo-matching tablets, orally, once daily for up to 6 weeks.
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5: Placebo Comparator |
Drug: Placebo
TAK-491 20 mg placebo-matching tablets, TAK-491 40 mg placebo-matching tablets, TAK-491 80 mg placebo-matching tablets, and olmesartan 40 mg placebo- matching capsules, orally, once daily for up to 6 weeks.
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Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled; only about one-third of patients continue to maintain control successfully.
TAK-491 is an angiotensin II receptor blocker and this study is being conducted to evaluate the efficacy and safety of oral TAK-491 compared to placebo and olmesartan in subjects with essential hypertension.
Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 11 weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting blood pressure and pulse, body height and weight, physical examinations and electrocardiograms. Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at 24 hour intervals.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Other agents that alter blood pressure, including:
Study Director: | VP Clinical Science Strategy | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | 01-05-TL-491-008 |
Study First Received: | June 10, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00696241 |
Health Authority: | United States: Food and Drug Administration |
Essential Hypertension Cardiovascular Disease High Blood Pressure Drug Therapy |
Vascular Diseases Olmesartan medoxomil Essential hypertension Angiotensin II Hypertension |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |