NCT00759551

Brief Summary

The purpose of this study is to determine the safety and efficacy of azilsartan, once daily (QD), in subjects with essential hypertension.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
555

participants targeted

Target at P75+ for phase_2 hypertension

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

10 months

First QC Date

September 24, 2008

Last Update Submit

June 17, 2010

Conditions

Hypertension

Keywords

Blood PressureDrug TherapySystolic PressureDiastolic PressureVascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in sitting clinic diastolic blood pressure.

    Week 8 or Final Visit

Secondary Outcomes (3)

  • Change from Baseline in sitting clinic systolic blood pressure.

    Weeks 2, 4, 6, and 8 or Final Visit

  • The change from Baseline in standing clinic diastolic blood pressure and systolic blood pressure.

    Weeks 2, 4, 6, and 8 or Final Visit

  • Change from Baseline in diastolic blood pressure and systolic blood pressure as measured by ambulatory blood pressure monitoring.

    Week 8 or Final Visit

Study Arms (7)

Azilsartan 2.5 mg QD

EXPERIMENTAL
Drug: Azilsartan

Azilsartan 5 mg QD

EXPERIMENTAL
Drug: Azilsartan

Azilsartan 10 mg QD

EXPERIMENTAL
Drug: Azilsartan

Azilsartan 20 mg QD

EXPERIMENTAL
Drug: Azilsartan

Azilsartan 40 mg QD

EXPERIMENTAL
Drug: Azilsartan

Placebo QD

PLACEBO COMPARATOR
Drug: Placebo

Olmesartan 20 mg QD

ACTIVE COMPARATOR
Drug: Olmesartan

Interventions

AzilsartanDRUG

Azilsartan 2.5 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.

Also known as: TAK-536
Azilsartan 2.5 mg QD
PlaceboDRUG

Azilsartan placebo-matching tablets, orally, once daily and olmesartan placebo-matching capsules, orally, once daily for up to 8 weeks.

Placebo QD
OlmesartanDRUG

Azilsartan placebo-matching tablets, orally, once daily and olmesartan 20 mg, capsules, orally, once daily for up to 8 weeks.

Also known as: Benicar®, Olmetec®
Olmesartan 20 mg QD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has mild to moderate uncomplicated essential hypertension (diastolic blood pressure between 95 and 114 mm Hg at Screening Day -7 and randomization visit).
  • Female patients of childbearing potential must be nonpregnant and nonlactating, and utilizing an acceptable method of contraception.
  • Is willing to discontinue current antihypertensive medications.

You may not qualify if:

  • Has a decrease of more than or equal to 8 mm Hg in clinic diastolic blood pressure between Screening Day -7 and randomization visit.
  • Is hypersensitive to angiotensin II receptor blockers.
  • The patient has Grade 3 or 4 hypertensive retinopathy (Keith-Wagener scale).
  • Has significant cardiac disease (eg, primary, hemodynamically significant cardiac valvular disease) other than mild to moderate uncomplicated hypertensive cardiovascular disease.
  • Has taken, within 7 days prior to placebo run-in, or is expected to take, medications known to affect blood pressure, including the following:
  • Diuretics
  • Anti-hypertensives
  • Vasodilators
  • Tricyclic antidepressants
  • Monoamine oxidase inhibitors
  • Phenothiazines
  • Diet medications
  • Amphetamines or their derivatives
  • Thiazolidinediones
  • Lithium
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionVascular Diseases

Interventions

azilsartanolmesartanOlmesartan Medoxomil

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • VP Clinical Science Strategy

    Takeda

    STUDY DIRECTOR

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

September 24, 2008

First Posted

September 25, 2008

Study Start

August 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

June 22, 2010

Record last verified: 2010-06