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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03251872 |
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Date of registration:
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13/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Olaparib for PAH: a Pilot Study
OPTION-p |
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Scientific title:
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Olaparib for Pulmonary Arterial Hypertension: a Pilot Clinical Study |
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Date of first enrolment:
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October 25, 2018 |
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Target sample size:
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6 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03251872 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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Canada
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Contacts
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Name:
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Sébastien Bonnet, PhD, FAHA |
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Address:
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Telephone:
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Email:
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Affiliation:
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IUCPQ-UL |
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Name:
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Steeve Provencher, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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IUCPQ-UL |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 1) adults (18-75 yrs) with PAH of idiopathic/ hereditary/drug or toxin-induced origin
or associated with connective tissue diseases; 2) mean PA pressure =25mmHg, PA wedge
pressure =15mmHg, PVR >480 dyn.s.cm-5 and absence of acute vasoreactivity (we expect
PARP1 inhibition will be most effective in patients with significant PA remodelling);
3) WHO functional class II or III; 4) clinically stable with unchanged vasoactive
therapy for =4 months; 5) two 6MWD of 150-550m and within ±15% of each other (the
latter being used as baseline value); 6) a negative serum pregnancy test prior to
receiving the first dose of study treatment and willing to use adequate contraception
from enrolment through 3 months after the last dose of study treatment for patients of
childbearing potential
Exclusion Criteria:
- 1) other types of pulmonary hypertension; 2) significant restrictive (total lung
capacity <60% predicted) or obstructive (FEV1/FVC<60% after a bronchodilator) lung
disease; 3) systolic blood pressure <90 mmHg; 4) acute RV failure within the last 3
months; 5) received any investigational drug within 30 days; 6) BMI <18 or >40 kg/m2;
7) cardiopulmonary rehabilitation program planned or started =12 weeks prior to Day 1;
8) presence of =3 risk factors for heart failure with preserved ejection fraction (BMI
>30 kg/m2, diabetes mellitus, hypertension or coronary artery disease); 9) organ
dysfunction other than RV failure; 10) anticipated survival <1 year due to concomitant
disease
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Olaparib
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Primary Outcome(s)
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Change in pulmonary vascular resistance (PVR) at week 16
[Time Frame: 16 weeks]
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Secondary ID(s)
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CER-21658
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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