Efficacy and Safety Study of Azilsartan Medoxomil Compared to Ramipril for Treating Essential Hypertension

NCT00760214 | Completed Phase 3 Results

• 3 other identifiers: 01-06-TL-491-0202007-002583-10U1111-1113-8982
• Study Type: interventional
• Target: 885
• Locations: 9 countries
• Sites: 68

Brief Summary

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.

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.

  Baseline and Week 24.

Secondary Outcomes (11)

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

  Baseline and Week 24.

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

  Baseline and Week 24.

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

  Baseline and Week 24.

• Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring

  Baseline and Week 24.

• Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring

  Baseline and Week 24.

Study Arms (3)

Azilsartan Medoxomil 40 mg QD

EXPERIMENTAL

Drug: Azilsartan medoxomil

Azilsartan Medoxomil 80 mg QD

EXPERIMENTAL

Drug: Azilsartan medoxomil

Ramipril 10 mg QD

ACTIVE COMPARATOR

Drug: Ramipril

Interventions

Azilsartan medoxomil DRUG

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.

Also known as: TAK-491, Edarbi

Azilsartan Medoxomil 40 mg QD

Ramipril DRUG

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.

Also known as: Tritace, Ramace, Altace

Ramipril 10 mg QD

Eligibility Criteria

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

You may qualify if:

• Essential hypertension (sitting systolic blood pressure between 150 and 180 mm Hg, inclusive).
• A female participant of childbearing potential who is sexually active agrees to use adequate contraception from screening throughout the duration of the study, and cannot be pregnant.
• Is willing to discontinue current antihypertensive medications at Screening Day -21. If the participant is on amlodipine prior to screening, the participant is willing to discontinue this medication at Screening Day -28.

You may not qualify if:

• Has an systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 114 mmHg at Randomization.
• Is taking or expected to take an excluded medication including antihypertensive agents, insulin or other agents that alter blood pressure.
• Is hypersensitive to angiotensin II receptor blockers and/or angiotensin-converting enzyme inhibitors.
• Has a recent history within the last 6 months 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 (eg, third-degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or flutter).
• Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
• Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).
• Is noncompliant (less than 70% or greater than 130%) with study medication during placebo run-in period.
• Has severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL/min/1.73 m² at Screening).
• Has known or suspected unilateral or bilateral renal artery stenosis.
• Has a history of drug or 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. (This criterion does not apply to those participants with basal cell or stage I squamous cell carcinoma of the skin).
• Has type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c greater than 8.0%) or is taking insulin.
• Has hyperkalemia as defined by the central laboratory normal reference range at Screening.
• Has an upper arm circumference less than 24 cm or greater than 42 cm.

Sponsors & Collaborators

• Takeda: lead

Study Sites (72)

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Paide, Estonia

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Tallinn, Estonia

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Tartu, Estonia

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Viljandi, Estonia

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Joensuu, Finland

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Mikkeli, Finland

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Tampere, Finland

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Turku, Finland

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Augsburg, Germany

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Bad Krozingen, Germany

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Bad Segeberg, Germany

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Berlin, Germany

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Cologne, Germany

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Dortmund, Germany

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Dresden, Germany

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Essen, Germany

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Frankfurt, Germany

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Goch, Germany

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Großheirath, Germany

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Hamburg, Germany

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Karlsruhe, Germany

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Künzing, Germany

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Leipzig, Germany

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Lübeck, Germany

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Mannheim, Germany

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München, Germany

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Nuremberg, Germany

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Siegen, Germany

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Deurne, Netherlands

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Ewijk, Netherlands

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Geleen, Netherlands

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Lichtenvoorde, Netherlands

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Oude Pekela, Netherlands

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Rijswijk, Netherlands

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Roelofarendsveen, Netherlands

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Rotterdam, Netherlands

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Wildervank, Netherlands

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Gdansk, Poland

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Gniewkowo, Poland

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Kamieniec Ząbkowicki, Poland

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Katowice, Poland

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Libiąż, Poland

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Lodz, Poland

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Oława, Poland

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Poznan, Poland

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Płock, Poland

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Skierniewice, Poland

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Tarnów, Poland

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Moscow, Russia

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Perm, Russia

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Saint Petersburg, Russia

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Belgrade, Serbia

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Niš, Serbia

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Niška Banja, Serbia

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Zemun, Serbia

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Bratislava, Slovakia

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Galanta, Slovakia

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Levice, Slovakia

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Lučenec, Slovakia

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Rimavská Sobota, Slovakia

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Boden, Sweden

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Gothenburg, Sweden

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Luleå, Sweden

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Lund, Sweden

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Malmo, Sweden

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Örebro, Sweden

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Skene, Sweden

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MeSH Terms

Conditions

Hypertension; Essential Hypertension; Vascular Diseases; Cardiovascular Diseases

Interventions

azilsartan medoxomil; azilsartan; Ramipril

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-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

• Medical Director

  Takeda Global Research & Development Center (Europe), Ltd.

  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: September 24, 2008
• First Posted: September 26, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 15, 2012
• Results First Posted: April 19, 2011

Record last verified: 2012-11

Locations

SE (7); BU (5); SL (5); RU (3); FI (4); DE (20); ES (4); NL (9); PL (11)