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lloprost

Phase 1

Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Bayer AG|Trials Updated: Sep 26, 2018

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

lloprost clinical trials

lloprost · 1 trial · 1 indication

Phase 1 1
NCT02032836Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)Pulmonary Arterial Hypertension
COMPLETED27 Analytics
PHASE1COMPLETED
Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)
Pulmonary Arterial HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

The proportion of patients with a meaningful maximum increase (i.e. >=25%) in heart rate AND/OR a meaningful maximum decrease (i.e. >=20%) in systolic blood pressure within the 30 minutes after the start of inhalation
multiple measurements within 30 minutes after iloprost inhalation

Secondary Endpoints

Maximum change in systolic, diastolic and mean arterial blood pressure
From baseline to multiple BP measurements within 2 hours after iloprost inhalation
Maximum change in heart rate within the 30 minutes following inhalation
From baseline to multiple HR measurements within 30 minutes after iloprost inhalation
Maximum change in oxygen saturation within the 30 minutes following inhalation using finger pulse oxymetry
From baseline to multiple measurements within 30 minutes after iloprost inhalation
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
I-Neb - FOXEXPERIMENTALPart 1: Subjects received single inhalation of 1.25 mcg iloprost using 10 mcg/ml iloprost solution (Ventavis 10) and then 2.5 mcg iloprost using Ventavis 10, both using the FOX nebulizer on Day 1. Part 2: On Day 2, subjects received single inhalation of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer; followed by single inhalation of 5 mcg iloprost using 20 mcg/ml iloprost solution (Ventavis 20) with the FOX nebulizer in a cross-over fashion. A washout period of at least 2 hours was maintained between treatments in Part 1 and Part 2. Part 3: Continued on Day 2, and through until Day 30, subjects received multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer for 2 weeks; followed by multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 20 with the FOX nebulizer for 2 weeks in a cross-over fashion.
FOX - I-NebEXPERIMENTALPart 1: Subjects received single inhalation of 1.25 mcg iloprost using 10 mcg/ml iloprost solution (Ventavis 10) and then 2.5 mcg iloprost using Ventavis 10, both using the FOX nebulizer on Day 1. Part 2: On Day 2, subjects received single inhalation of 5 mcg iloprost using 20 mcg/ml iloprost solution (Ventavis 20) with the FOX nebulizer; followed by single inhalation of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer in a cross-over fashion. A wash-out period of at least 2 hours was maintained between treatments in Part 1 and Part 2. Part 3: Continued on Day 2, and through until Day 30, subjects received multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 20 with the FOX nebulizer for 2 weeks; followed by multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer for 2 weeks in a cross-over fashion.

Interventions

NameTypeDescription
lloprost(Ventavis,BAYQ6252, 20 µg/mL)DRUG20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer
lloprost(Ventavis,BAYQ6252, 10 µg/mL)DRUG10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Male or female aged ≥ 18 years * Current diagnosis of pulmonary hypertension (updated Dana Point Classification 1). * Current inhalative therapy with 5 µg iloprost using the I-Neb nebulizer * WHO functional class III at the time of the patient's commencement of inhalative ther...

Countries:AustriaGermany
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Frequently asked questions about lloprost

What is lloprost used for?

lloprost is being developed for the treatment of Pulmonary Arterial Hypertension, a cardiovascular condition. It is an investigational small molecule studied by Bayer AG. The clinical program has focused on patients with PAH, with one completed Phase 1 trial that enrolled 27 participants.

Who is developing lloprost?

lloprost is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer AG is the sponsor of the clinical program for this small molecule in Pulmonary Arterial Hypertension.

What phase is lloprost in?

lloprost is in Phase 1 clinical development. The program has one completed Phase 1 trial and no active trials at this time. It is an investigational agent and has not been approved for any indication.

What clinical trials is lloprost in?

lloprost has been studied in one completed Phase 1 trial, NCT02032836, titled Comparative PK PD Study in PAH Patients (Fox vs. I-Neb). The trial enrolled 27 participants with Pulmonary Arterial Hypertension across Austria and Germany. It was randomized and controlled, with no healthy volunteers.

Is lloprost the same as Ventavis or BAYQ6252?

Yes, lloprost is also known as Ventavis and BAYQ6252. The 20 µg/mL formulation is referenced in the alternative names. These names refer to the same small molecule developed by Bayer AG for Pulmonary Arterial Hypertension.