Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension

NCT00591266 | Completed Phase 3 Results

• 2 other identifiers: 01-05-TL-491-010U1111-1113-9132
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 50

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine alone.

Conditions

Hypertension

Keywords

Blood pressure; blood pressure monitoring ambulatory; Drug Therapy

Outcome Measures

Primary Outcomes (1)

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

  The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

  Baseline and Week 6.

Secondary Outcomes (14)

• Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.

  Baseline and Week 6.

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

  Baseline and Week 6.

• Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure

  Baseline and Week 6.

• Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

  Baseline and Week 6.

• Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

  Baseline and Week 6.

Study Arms (3)

Azilsartan Medoxomil 40 mg QD and Amlodipine 5 mg QD

EXPERIMENTAL

Drug: Azilsartan Medoxomil and amlodipine

Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD

EXPERIMENTAL

Drug: Azilsartan Medoxomil and amlodipine

Amlodipine 5 mg QD

ACTIVE COMPARATOR

Drug: Amlodipine

Interventions

Azilsartan Medoxomil and amlodipine DRUG

Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.

Also known as: Norvasc, TAK-491, Edarbi

Azilsartan Medoxomil 40 mg QD and Amlodipine 5 mg QD

Amlodipine DRUG

Azilsartan medoxomil placebo-matching tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.

Also known as: Norvasc

Amlodipine 5 mg QD

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 and 24-hour mean systolic blood pressure greater than or equal to 140 mm Hg and less than or equal to 180 mm Hg.
• 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
• Is willing to discontinue current antihypertensive medications.

You may not qualify if:

• Has sitting trough clinic diastolic blood pressure greater than 119 mm Hg.
• Has a baseline 24 hour ambulatory blood pressure monitoring reading of insufficient quality.
• The subject is hypersensitive to angiotensin II receptor blockers or calcium channel blockers.
• Has a recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
• Has clinically significant cardiac conduction defects.
• Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
• Has secondary hypertension of any etiology
• Is non-compliant with study medication during placebo run-in period.
• Has severe renal dysfunction or disease.
• Has known or suspected unilateral or bilateral renal artery stenosis.
• Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
• Has a previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
• Has type 1 or poorly controlled type 2 diabetes mellitus.
• Has hyperkalemia as defined by the central laboratory normal reference range,
• Has an alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease or jaundice.

Sponsors & Collaborators

• Takeda: lead

Study Sites (50)

Unknown Facility

Mesa, Arizona, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Burbank, California, United States

Location

Unknown Facility

Burlingame, California, United States

Location

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

Roseville, California, United States

Location

Unknown Facility

Tustin, California, United States

Location

Unknown Facility

Wheat Ridge, Colorado, United States

Location

Unknown Facility

Newark, Delaware, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Hialeah, Florida, United States

Location

Unknown Facility

Longwood, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Honolulu, Hawaii, United States

Location

Unknown Facility

Boise, Idaho, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Gurnee, Illinois, United States

Location

Unknown Facility

Peoria, Illinois, United States

Location

Unknown Facility

Elkhart, Indiana, United States

Location

Unknown Facility

Crestview Hills, Kentucky, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Riverdale, Maryland, United States

Location

Unknown Facility

Brockton, Massachusetts, United States

Location

Unknown Facility

Haverhill, Massachusetts, United States

Location

Unknown Facility

North Dartmouth, Massachusetts, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Akron, Ohio, United States

Location

Unknown Facility

Canton, Ohio, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Mogadore, Ohio, United States

Location

Unknown Facility

Norman, Oklahoma, United States

Location

Unknown Facility

Tulsa, Oklahoma, United States

Location

Unknown Facility

Warminster, Pennsylvania, United States

Location

Unknown Facility

Cumberland, Rhode Island, United States

Location

Unknown Facility

Arlington, Texas, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Carrollton, Texas, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Irvine, Texas, United States

Location

Unknown Facility

Lake Jackson, Texas, United States

Location

Unknown Facility

North Richland Hills, Texas, United States

Location

Unknown Facility

Manassas, Virginia, United States

Location

Unknown Facility

Renton, Washington, United States

Location

Unknown Facility

Menomonee Falls, Wisconsin, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

azilsartan medoxomil; Amlodipine; azilsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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

• Executive Medical Director Clinical Science

  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

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: October 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 22, 2011
• Results First Posted: April 19, 2011

Record last verified: 2011-07

Locations

US (50)