Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension

NCT00362115 | Completed Phase 2 Results

• 2 other identifiers: 01-05-TL-491-005U1111-1113-8783
• Study Type: interventional
• Target: 449
• Locations: 4 countries
• Sites: 54

Brief Summary

The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with hypertension.

Conditions

Hypertension

Keywords

hypertension; blood pressure; diastolic blood pressure; drug therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Sitting Clinic Diastolic Blood Pressure.

  The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.

  Baseline and Week 8.

Secondary Outcomes (19)

• Change From Baseline in Sitting Clinic Systolic Blood Pressure.

  Baseline and Week 8

• Change From Baseline in Standing Clinic Systolic Blood Pressure.

  Baseline and Week 8.

• Change From Baseline in Standing Clinic Diastolic Blood Pressure.

  Baseline and Week 8.

• Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

  Baseline and Week 8.

• Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

  Baseline and Week 8.

Study Arms (7)

Azilsartan Medoxomil 5 mg QD

EXPERIMENTAL

Drug: Azilsartan Medoxomil

Azilsartan Medoxomil 10 mg QD

EXPERIMENTAL

Drug: Azilsartan Medoxomil

Azilsartan Medoxomil 20 mg QD

EXPERIMENTAL

Drug: Azilsartan Medoxomil

Azilsartan Medoxomil 40 mg QD

EXPERIMENTAL

Drug: Azilsartan Medoxomil

Azilsartan Medoxomil 80 mg QD

EXPERIMENTAL

Drug: Azilsartan Medoxomil

Olmesartan 20 mg QD

ACTIVE COMPARATOR

Drug: Olmesartan

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Azilsartan Medoxomil DRUG

Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.

Also known as: TAK-491, Edarbi

Azilsartan Medoxomil 5 mg QD

Olmesartan DRUG

Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.

Also known as: Benicar

Olmesartan 20 mg QD

Placebo DRUG

Matching placebo tablets, orally, once daily for up to 8 weeks.

Placebo QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate uncomplicated essential hypertension.
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Must be in good health as determined by a physician.
• The subject has clinical laboratory evaluations within the reference range for the testing laboratory unless the results are deemed not clinically significant by the investigator or sponsor.
• The subject is willing to discontinue current antihypertensive medications at Screening Day minus 21.

You may not qualify if:

• Diastolic blood pressure less than 95 or greater than 114 mmHg at Placebo Run-in Day minus 14 or Randomization visit, or systolic blood pressure greater than 180 mm Hg.
• Decrease of more than or equal to 8 mm Hg in clinic diastolic blood pressure between Placebo Run-in Day minus 14 and Randomization visit.
• Has taken within 7 days prior to placebo run-in, or is expected to take medications known to affect blood pressure and 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:
• Hypersensitive to angiotensin II receptor blockers.
• History of an acute myocardial infarction within 12 months prior to Screening, history of coronary revascularization within 6 months prior to Screening, or any history of heart failure, post-myocardial infarction angina, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
• Clinically significant cardiac conduction defects (eg, 3rd degree atrioventricular block, left bundle branch block, atrial fibrillation or flutter).
• Secondary hypertension of any etiology.
• Upper arm circumference less than 24 or greater than 42 cm.
• Works night (3rd) shift (defined as 11pm to 7am).
• Non-compliant (less than 80%) with study medication during Placebo Run-in period.
• Significant, moderate to severe renal dysfunction (confirmed by serum creatinine of greater than 2 mg per dl or disease (including renal artery stenosis or known nephrotic proteinuria).
• History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
• Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin).
• Type 1 or uncontrolled type 2 diabetes mellitus (confirmed by glycosylated hemoglobin greater than 9.5%).
• Alanine transaminase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.

Sponsors & Collaborators

• Takeda: lead

Study Sites (54)

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Huntsville, Alabama, United States

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Ozark, Alabama, United States

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Mesa, Arizona, United States

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Little Rock, Arkansas, United States

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Carmichael, California, United States

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Long Beach, California, United States

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San Diego, California, United States

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Tustin, California, United States

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Denver, Colorado, United States

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Stamford, Connecticut, United States

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Trumbull, Connecticut, United States

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Waterbury, Connecticut, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Pinellas Park, Florida, United States

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Atlanta, Georgia, United States

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Evansville, Indiana, United States

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Shawnee Mission, Kansas, United States

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Auburn, Maine, United States

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Trenton, New Jersey, United States

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Binghamtom, New York, United States

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Rochester, New York, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Concord, North Carolina, United States

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Hickory, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Anderson, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Simpsonville, South Carolina, United States

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Bristol, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Euless, Texas, United States

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North Richland Hills, Texas, United States

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San Antonio, Texas, United States

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Lakewood, Washington, United States

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Renton, Washington, United States

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Madison, Wisconsin, United States

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BA, Argentina

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Córdoba, Argentina

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Ushuaia, Argentina

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Guadalajara, Jal, Mexico

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Mexico City, Mexico

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Monterrey Nuevo Leon, Mexico

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Morelia, Michoacan, Mexico

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Lima, Peru

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MeSH Terms

Conditions

Hypertension

Interventions

azilsartan medoxomil; azilsartan; olmesartan; Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• VP Clinical Science Strategy

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 7, 2006
• First Posted: August 9, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 19, 2011
• Results First Posted: April 19, 2011

Record last verified: 2011-03

Locations

PE (1); ME (4); US (46); AR (3)