A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1)
NCT ID: NCT03924154
Last Updated: 2020-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2019-08-01
2020-02-24
Brief Summary
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Detailed Description
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Study participation for each patient will last approximately 3 months and will consist of a screening period (up to 28 days in duration), a baseline period (day 1, pre-dose), a 6-week treatment period, and a 2-week follow-up period.
The study will enroll approximately 36 patients at approximately 20 centers across the United States and Canada.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Arm 1 (n=24) - RVT-1201 Treatment: RVT-1201 immediate-release tablets will be administered orally, at a dose of 600 mg twice daily (BID), for a total of 6 weeks in addition to the patient's current standard of care (SOC) medication(s) for PAH.
* Arm 2 (n=12) - Placebo Treatment: Matching placebo tablets will be administered orally, at a dose of 600 mg twice daily (BID), for a total of 6 weeks in addition to the patient's current SOC medication(s) for PAH.
Participants will be followed in face-to-face visits with trial personnel every 2 weeks for 8 weeks (6 weeks of treatment plus a 2-week follow-up), with an additional phone call at Week 1, to assess drug effects and monitor safety during their treatments.
TREATMENT
DOUBLE
Study Groups
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RVT-1201
RVT-1201 600 mg immediate-release tablet, administered orally twice daily with food for 6 weeks, in addition to the patient's current standard of care medication(s) for PAH (n=24 \[Anticipated\])
RVT-1201
RVT-1201 600 mg immediate-release tablet
Placebo
Matching placebo tablet, administered orally twice daily with food for 6 weeks, in addition to the patient's current standard of care medication(s) for PAH (n=12 \[Anticipated\])
Placebo
Inactive pill manufactured to mimic RVT-1201 600 mg immediate-release tablet
Interventions
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RVT-1201
RVT-1201 600 mg immediate-release tablet
Placebo
Inactive pill manufactured to mimic RVT-1201 600 mg immediate-release tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Idiopathic
* Heritable
* Drug- or toxin- induced
* Associated with one of the following: connective tissue disease or congenital heart disease
* World Health Organization (WHO) Functional Class (FC) II or III
* PAH diagnosed by right heart cardiac catheterization prior to Screening
* Receiving standard of care treatment for PAH with oral monotherapy or dual therapy for at least 12 weeks prior to Screening at a dose which has been stable for at least 8 weeks prior to Screening
* If on a diuretic, dose must be stable for at least 4 weeks prior to Screening, with no changes anticipated during study participation
* 6-Minute Walk Distance (6MWD) between 150 and 500 meters at Screening and Baseline visits
* Plasma N-terminal pro B-type natriuretic peptide (NT-proBNP) level ≥ 300 pg/mL at Screening
* Ability and willingness to give written informed consent and to comply with the requirements of the study
Exclusion Criteria
* Other types of pulmonary hypertension (PH):
* Pulmonary hypertension due to left heart disease (WHO PH Group 2)
* Pulmonary hypertension due to lung diseases and/or hypoxia (WHO PH Group 3)
* Chronic thromboembolic pulmonary hypertension (WHO PH Group 4)
* Pulmonary hypertension with unclear multifactorial mechanisms (WHO PH Group 5)
* Hospitalization for pulmonary hypertension within 12 weeks of screening
* Cardiopulmonary rehabilitation program based on exercise (planned, or started ≤ 12 weeks prior to Screening)
* Prostanoid or prostacyclin receptor agonist therapy within 12 weeks of screening
* Evidence of left-sided heart disease
* If Pulmonary function tests were done prior to screening, Pulmonary function tests demonstrate obstructive or restrictive lung disease
* Use of telotristat (Xermelo®) within the last 6 months
* Use of any investigational drug within 30 days or five half-lives (whichever is longer) prior to Screening, or 90 days if an investigational drug for PAH
* Have uncontrolled atrial fibrillation (AFib) or other uncontrolled arrhythmias
* Body mass index (BMI) \>45 kg/m2
* Women of childbearing potential who are pregnant, planning to become pregnant, or lactating or female/male patients unwilling to use effective contraception
18 Years
75 Years
ALL
No
Sponsors
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Altavant Sciences, Inc.
UNKNOWN
PPD Development, LP
INDUSTRY
Altavant Sciences GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Ed Parsley, DO
Role: STUDY_DIRECTOR
Altavant Sciences
Locations
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Pulmonary Associates, PA
Phoenix, Arizona, United States
University of California Davis Medical Center
Sacramento, California, United States
SBPA Research LLC
Santa Barbara, California, United States
University of Colorado
Aurora, Colorado, United States
George Washington Medical Faculty Associates - Pulmonary Hypertension Program
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Kentuckiana Pulmonary Research Center
Louisville, Kentucky, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
Countries
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Other Identifiers
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RVT-1201-2001
Identifier Type: -
Identifier Source: org_study_id
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