[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

+18566613721

Email address

clinical-trials-disclosure@idorsia.com

Condition

Insomnia Disorder

Treatment type

Interventional

Investigational product

ACT-541468 10 mg

Phase

Phase 3

Sponsor

Idorsia Pharmaceuticals Ltd.

ClinicalTrials.gov identifier

NCT03679884

Study number

ID078A303

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About the study

Study to assess the long term safety and tolerability of ACT-541468 in adult and elderly subjects suffering from difficulties to sleep

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Signed informed consent prior to any study-mandated procedure (Visit 1).
  2. Having completed the DB study treatment and the run-out period of ID-078A301 or ID‒078A302 (Visit 1).
  3. For woman of childbearing potential, the following is required:
  4. Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)
  5. Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.
Exclusion criteria
  1. Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1).
  2. For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
  3. Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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Find a Study Site