A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension

NCT00696384 | Completed Phase 3 Results

• 2 other identifiers: 01-06-TL-491-016U1111-1113-9088
• Study Type: interventional
• Target: 418
• Locations: 3 countries
• Sites: 45

Brief Summary

The purpose of this study is to determine the long term safety and tolerability of azilsartan medoxomil, once daily (QD), in participants with Essential Hypertension.

Conditions

Hypertension

Keywords

Essential Hypertension; Cardiovascular Disease; High Blood Pressure; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Double-blind Baseline (Week 26) in Sitting Clinic Diastolic Blood Pressure to Week 32

  The change in sitting clinic diastolic blood pressure measured at final visit or week 32 from Double-blind Baseline/Week 26. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements. Each participant's blood pressure at the Final Visit/Week 26 of the open-label phase represented their Baseline blood pressure for the double-blind reversal phase.

  Double-blind Baseline (Week 26) and Week 32.

Secondary Outcomes (5)

• Change From Double-blind Baseline (Week 26) in Sitting Clinic Systolic Blood Pressure to Week 32

  Double-blind Baseline (Week 26) and Week 32.

• Change From Open Label Baseline (Week 0) in Sitting Clinic Diastolic Blood Pressure to Week 26

  Baseline and Week 26.

• Change From Open Label Baseline (Week 0) in Sitting Clinic Systolic Blood Pressure to Week 26

  Baseline and Week 26.

• Number of Participants With Adverse Events During the Open-Label Phase

  Baseline to Week 26

• Number of Participants With Adverse Events in the Double-Blind Baseline Phase

  Double-blind Baseline/Week 26 to Week 32

Study Arms (3)

Azilsartan Medoxomil QD-Open Label Phase (Baseline - Week 26)

EXPERIMENTAL

Drug: Azilsartan medoxomil

Azilsartan Medoxomil QD - Double-Blind Phase (Week 26-32)

EXPERIMENTAL

Drug: Azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin II receptor blocker antihypertensive medications.

Placebo QD - Double-Blind Phase (Week 26- 32)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Azilsartan medoxomil DRUG

All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as \<140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and \<130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks. Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit.

Also known as: TAK-491, Edarbi

Azilsartan Medoxomil QD-Open Label Phase (Baseline - Week 26)

Azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin II receptor blocker antihypertensive medications. DRUG

Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks/Week 32.

Also known as: TAK-491, Edarbi

Azilsartan Medoxomil QD - Double-Blind Phase (Week 26-32)

Placebo DRUG

Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other non-ARB antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks/Week 32.

Placebo QD - Double-Blind Phase (Week 26- 32)

Eligibility Criteria

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

You may qualify if:

• Has essential hypertension (diastolic blood pressure ≥ 95mm Hg and ≤ 119 mm Hg. For participants with diabetes or chronic kidney disease diastolic blood pressure must be ≥ 85 mm Hg and ≤ to 109 mm Hg.
• Female participant is not of childbearing potential (eg, sterilized, postmenopausal).
• Female participants 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.

You may not qualify if:

• Systolic blood pressure greater than 185 mm Hg.
• Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• Is hypersensitive to AII receptor blockers.
• Recent history (within the last 6 months) of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, cerebrovascular accident, or transient ischemic attack.
• History of moderate to severe heart failure or hypertensive encephalopathy.
• Has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome).
• Has secondary hypertension of any etiology.
• Known or suspected unilateral or bilateral renal artery stenosis.
• Has severe renal dysfunction or disease (based on calculated creatinine clearance \< 30 mL/min/1.73 m2) at Screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (45)

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Huntsville, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Tempe, Arizona, United States

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Los Gatos, California, United States

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Sacramento, California, United States

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Tustin, California, United States

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Westlake Village, California, United States

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Colorado Springs, Colorado, United States

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Wheat Ridge, Colorado, United States

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Melbourne, Florida, United States

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Pembroke Pines, Florida, United States

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Augusta, Georgia, United States

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South Bend, Indiana, United States

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Auburn, Maine, United States

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Marlborough, Massachusetts, United States

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Chelsea, Michigan, United States

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St Louis, Missouri, United States

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Trenton, New Jersey, United States

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Rochester, New York, United States

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Burlington, North Carolina, United States

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Wilmington, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Carlisle, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, 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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Berazategui, Buenos Aires, Argentina

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Pilar, Buenos Aires, Argentina

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Córdoba, Argentina

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Salta, Argentina

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León, Guanajuato, Mexico

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Guadalajara, Jalisco, Mexico

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Cuernavaca, Morelos, Mexico

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Rosario, Santa Fe, Mexico

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Tampico, Tamaulipas, Mexico

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Durango, Mexico

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Mexico City, Mexico

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Puebla City, Mexico

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Related Publications (1)

• Kipnes MS, Handley A, Lloyd E, Barger B, Roberts A. Safety, tolerability, and efficacy of azilsartan medoxomil with or without chlorthalidone during and after 8 months of treatment for hypertension. J Clin Hypertens (Greenwich). 2015 Mar;17(3):183-92. doi: 10.1111/jch.12474. Epub 2015 Jan 24.

  PMID: 25619410 DERIVED

MeSH Terms

Conditions

Hypertension; Essential Hypertension; Cardiovascular Diseases

Interventions

azilsartan medoxomil; azilsartan

Condition Hierarchy (Ancestors)

Vascular Diseases

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: June 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 4, 2012
• Results First Posted: January 4, 2012

Record last verified: 2011-11

Locations

US (33); ME (8); AR (4)