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| Sponsor: | Takeda Global Research & Development Centre (Europe) Ltd. |
|---|---|
| Information provided by: | Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00760214 |
Purpose
The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to ramipril for treating Essential Hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Azilsartan medoxomil Drug: Ramipril |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Ramipril in Subjects With Essential Hypertension |
| Enrollment: | 885 |
| Study Start Date: | January 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Azilsartan Medoxomil 40 mg QD |
Drug: Azilsartan medoxomil
Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
Other Names:
|
| Experimental: Azilsartan Medoxomil 80 mg QD |
Drug: Azilsartan medoxomil
Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
Other Names:
|
| Active Comparator: Ramipril 10 mg QD |
Drug: Ramipril
Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
Other Names:
|
A major component of blood pressure regulation is the renin-angiotensin-aldosterone system, a system of hormone-mediated feedback interactions that results in the relaxation or constriction of blood vessels in response to various stimuli. Angiotensin II, a polypeptide hormone, is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme as part of the renin-angiotensin-aldosterone system. Angiotensin II is the principal pressor agent of the renin-angiotensin-aldosterone system with a myriad of effects on the cardiovascular system and on electrolyte homeostasis. Two receptors for angiotensin II have been identified. Angiotensin II type 1 receptors are located predominantly in vascular smooth muscle, where activation by angiotensin II results in vasoconstriction, hypertrophic proliferation, and inflammation. In contrast, stimulation of angiotensin II type 2 receptors by angiotensin II results in vasodilatation, antiproliferative effects that are opposite from those of angiotensin II type 1 receptor stimulation.
Drugs that modulate the renin-angiotensin-aldosterone system are used commonly worldwide for the treatment of hypertension. Of these, some block the synthesis of angiotensin II by inhibiting angiotensin-converting enzymes, while others inhibit the action of angiotensin II by binding directly to the angiotensin II type 1 receptor (called angiotensin II receptor blockers), thereby causing vasodilatation of blood vessels, resulting in a reduction in blood pressure. The effects of angiotensin II receptor blockers on other conditions in which the renin-angiotensin-aldosterone system plays a significant role, such as congestive heart failure, postmyocardial infarction management and diabetic nephropathy have also been investigated.
Although antihypertensive agents are effective at the appropriate dose, the majority have side effects that limit their use. Angiotensin-converting enzyme inhibitors are commonly associated with cough and more rarely with angioedema. Beta-blockers are associated with fatigue and erectile dysfunction, calcium antagonists with peripheral edema and diuretics with metabolic complications. As a class, angiotensin II receptor blockers generally are considered more tolerable than other classes of hypertensive agents, although there is still a need for compounds with improved tolerability and efficacy for the treatment of hypertension.
TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker with high affinity for, and selective antagonistic activity at, the angiotensin II type 1 receptor, and is being developed for clinical use as an antihypertensive agent.
Ramipril is an angiotensin-converting enzyme inhibitor widely prescribed in Europe and Asia for the treatment of mild to moderate essential hypertension.
This study is designed to compare the efficacy and safety/tolerability of azilsartan medoxomil and ramipril for the treatment of hypertension.
Participants in this study will be seen twice during the first month, then once a month for five months. Participants will also be required to fast for 8 hours prior to each visit to the study center. Total duration of study participation is 24-weeks, plus a safety follow up phone call after the study has ended.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 72 Study Locations| Study Director: | Medical Director | Takeda Global Research & Development Center (Europe), Ltd. |
More Information
| Responsible Party: | VP Clinical Science, Takeda Global Research & Development Centre (Europe), Ltd.. |
| ClinicalTrials.gov Identifier: | NCT00760214 History of Changes |
| Other Study ID Numbers: | 01-06-TL-491-020, 2007-002583-10, U1111-1113-8982 |
| Study First Received: | September 24, 2008 |
| Results First Received: | March 24, 2011 |
| Last Updated: | March 24, 2011 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Russia: Ministry of Health and Social Development of the Russian Federation Slovakia: State Institute for Drug Control Ukraine: State Pharmacological Center - Ministry of Health Sweden: Medical Products Agency Serbia and Montenegro: Agency for Drugs and Medicinal Devices Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
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Essential Hypertension Hypertension Drug Therapy |
Blood Pressure, High Vascular Disease Cardiovascular Disease |
|
Hypertension Vascular Diseases Cardiovascular Diseases Ramipril Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |