Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Takeda Global Research & Development Center, Inc. |
---|---|
Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00759551 |
The purpose of this study is to determine the safety and efficacy of TAK-536 in subjects with essential hypertension.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: TAK-536 Drug: Placebo Drug: Olmesartan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Efficacy, Safety, and Tolerability of TAK-536 in Patients With Mild to Moderate Uncomplicated Essential Hypertension |
Enrollment: | 555 |
Study Start Date: | August 2004 |
Study Completion Date: | June 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: TAK-536
TAK-536 2.5 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.
|
2: Experimental |
Drug: TAK-536
TAK-536 5.0 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.
|
3: Experimental |
Drug: TAK-536
TAK-536 10 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.
|
4: Experimental |
Drug: TAK-536
TAK-536 20 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.
|
5: Experimental |
Drug: TAK-536
TAK-536 40 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.
|
6: Placebo Comparator |
Drug: Placebo
TAK-536 placebo-matching tablets, orally, once daily and olmesartan placebo-matching capsules, orally, once daily for up to 8 weeks.
|
7: Active Comparator |
Drug: Olmesartan
TAK-536 placebo-matching tablets, orally, once daily and olmesartan 20 mg, capsules, orally, once daily for up to 8 weeks.
|
According to the National Health and Nutrition Examination Survey, approximately 60 million people in the United States are hypertensive. Although no single risk factor is responsible for the development of hypertension, some of the many risk factors can be controlled, and some cannot. Controllable risk factors include weight gain, smoking, a sedentary lifestyle, poor eating habits, emotional stress, physical tension, sodium sensitivity, alcohol abuse, and use of oral contraceptives. Uncontrollable risk factors include family history, gender, age and race.
Hypertension is termed the "silent killer" because many patients are asymptomatic. Chronic hypertension causes extensive arterial wall damage, which allows cholesterol to adhere to the damaged endothelial lining and produces increased cardiac stress. Hypertension dramatically increases the risk of myocardial infarction, stroke, renal damage, impaired vision, heart failure and overall mortality. Angiotensin II receptor blockers are a class of drugs used for the treatment of hypertension that not only decrease blood pressure, but also likely contribute to protecting hypertensive individuals from cardiac events, strokes and loss of renal function.
Angiotensin II has significant physiological effects on tissues and organs throughout the body including vascular smooth muscle, adrenal cortex, kidney, and brain. Angiotensin II receptors are located on the plasma membrane of target cells to facilitate the rapid onset of angiotensin II. Three distinct subtypes of angiotensin II receptors have been identified: angiotensin II type-1 receptor, angiotensin type 2, and angiotensin type 4; and the relative proportion of each vary from tissue to tissue. The angiotensin II type-1 receptor subtype is expressed predominantly in vascular smooth muscle cells where activation by angiotensin II results in vasoconstriction, cell proliferation, fibrosis, and cellular hypertrophy. In contrast, angiotensin II type-2 receptor stimulation produces pharmacologic activities that are opposite to those that occur after angiotensin II type-1 receptor stimulation. The angiotensin II type-4 receptor has been reported to be expressed in the adrenals, brain, and myocardium, but its exact function remains unknown. It is not considered to play an important role in human pathogenesis.
TAK-536 is a synthetic angiotensin II type-1 receptor antagonist being developed as a treatment for mild to moderate uncomplicated essential hypertension
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Has taken, within 7 days prior to placebo run-in, or is expected to take, medications known to affect blood pressure, including the following:
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | 01-03-TL-536-002 |
Study First Received: | September 24, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00759551 |
Health Authority: | United States: Food and Drug Administration |
Blood Pressure Drug Therapy Systolic Pressure Diastolic Pressure Vascular Diseases |
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 |