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Cholecalciferol, Miglyol oil

Phase 2

Chronic Obstructive Pulmonary Disease | Unknown | Other |United Therapeutics Corporation|Last Updated: Feb 4, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00977873Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary DiseasePHASE2 COMPLETED 240Sep 1, 2009Jul 1, 2013Feb 4, 20144 United Kingdom
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Study Endpoints
Primary Endpoints
Time to first upper respiratory tract infection
One year
Time to first moderate / severe COPD exacerbation
One year
Secondary Endpoints
Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease
One year
Proportion of participants experiencing hypercalcaemia
One year
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Vigantol oilACTIVE_COMPARATORVigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
Miglyol oilPLACEBO_COMPARATORMiglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
Interventions
NameTypeDescription
CholecalciferolDIETARY_SUPPLEMENTCholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Miglyol oilDIETARY_SUPPLEMENTMiglyol oil will be administered in 2-monthly bolus doses over a period of one year
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Principal Inclusion Criteria: * Medical record diagnosis of COPD, emphysema or bronchitis * Post-bronchodilator FEV1 / FVC \< 70% or post-bronchodilator FEV1 / slow VC \< 70% * Post-bronchodilator FEV1 \< 80% predicted * Age ≥ 40 years on day of first dose of IMP * Smoking history ≥ 15 pack-years *...

Countries:United Kingdom
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