Not Yet RecruitingPhase 2ACTRN12605000689673

An initial factorial evaluation of the potential synergy between two novel agents (CB0011 and CB0012) for the treatment of Obstructive Sleep Apnea Syndrome


Sponsor

Cypress Bioscience, Inc

Enrollment

100 participants

Start Date

Sep 3, 2006

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 21 Yearss

Inclusion Criteria1

  • Subjects must have a current diagnosis of Obstructive Sleep Apnea Syndrome, have an apnea-hypopnea index (AHI) of between 10-40 (using a strict definition of hypopnea), with a calculated BMI equal or less than 40 at the time of study entry.

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Interventions

A four week 1:1:1:1:1 randomised study in patients with diagnosed Obstructive Sleep Apnea Syndrome. 100 completed patients, 20 to be randomised to CB0012 alone at two different sequential doses, 20 pa

A four week 1:1:1:1:1 randomised study in patients with diagnosed Obstructive Sleep Apnea Syndrome. 100 completed patients, 20 to be randomised to CB0012 alone at two different sequential doses, 20 patients to be randomised to 15mg of CB0011 and CB0012 at two different sequential doses, 20 patients to be randomised to 30mg of CB0011 and CB0012 at two different sequential doses, 20 patients to be randomised to CB0011 alone, and 20 patients to be randomised to placebo.


Locations(1)

Australia

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