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Trial record 1 of 3 for:    rodatristat ethyl | Recruiting, Not yet recruiting Studies | Pulmonary Arterial Hypertension
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A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

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ClinicalTrials.gov Identifier: NCT04712669
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Altavant Sciences GmbH

Tracking Information
First Submitted Date  ICMJE January 12, 2021
First Posted Date  ICMJE January 15, 2021
Last Update Posted Date August 20, 2021
Actual Study Start Date  ICMJE March 15, 2021
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2021)
Change from baseline of pulmonary vascular resistance as measured by right heart catheterization [ Time Frame: From initiation to Week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2021)
Change from baseline of pulmonary vascular resistance as measured by right heart catherization [ Time Frame: From initiation to Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2021)
  • Change from baseline of cardiac index (CI) [ Time Frame: From initiation to Week 24 ]
  • Change from baseline of mean pulmonary artery pressure (mPAP) [ Time Frame: From initiation to Week 24 ]
  • Change from baseline of mean mixed venous oxygen saturation (SvO2) [ Time Frame: From initiation to Week 24 ]
  • Change from baseline of pulmonary artery compliance (PAC) [ Time Frame: From initiation to Week 24 ]
  • Time to the first occurrence of a clinical worsening event (TTCW) [ Time Frame: From initiation to Week 24 ]
    Time to Clinical Worsening (TTCW) defined as the first occurrence of: 1. Death from any cause, 2. Hospitalization for worsening PAH (any hospitalization for worsening PAH, lung or heart and lung transplantation, atrial septostomy, or initiation of parenteral prostanoid therapy), 3. Disease progression defined as a decrease of more than 15% from Baseline in the 6-minute walk distance (6MWD) combined with World Health Organization (WHO) Functional Class (FC) III or IV symptoms at 2 consecutive visits separated by at least 14 days (adjudicated)
  • Change in baseline in WHO FC World Health Organization (WHO) Functional Class (FC) [ Time Frame: From initiation to Week 24 ]
  • Change from baseline in 6MWD [ Time Frame: From initiation to Week 24 ]
  • Change from baseline in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) levels [ Time Frame: From initiation to Week 24 ]
  • Change from baseline in of right atrial size by echocardiogram [ Time Frame: From initiation to Week 24 ]
  • Change from baseline in the tricuspid annular systolic velocity by echocardiogram [ Time Frame: From initiation to Week 24 ]
  • Change from baseline in the tricuspid annular plane systolic excursion (TAPSE) by echocardiogram [ Time Frame: From initiation to Week 24 ]
  • Change from baseline in the RV fractional area change by echocardiogram [ Time Frame: From initiation to Week 24 ]
  • Change in baseline in the Pulmonary Arterial Hypertension Symptoms and Impact Questionnaire (PAH SYMPACT) Score [ Time Frame: From initiation to Week 24 ]
  • Change in baseline in the Registry to Evaluate Early and Long Term PAH Disease Management (REVEAL) Lite 2 score [ Time Frame: From initiation to Week 24 ]
  • Change from baseline in plasma and urine 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: From initiation to Week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 13, 2021)
  • Time to Clinical Improvement (TTCI) [ Time Frame: From initiation to Week 24 ]
    A > 10% increase in 6MWD or 30 meters AND an improvement to or maintenance of WHO FC II symptomatology, in the absence of a deterioration in clinical condition or death during the 24 weeks of the Main Study
  • Change from baseline on the following actigraphy endpoints: [ Time Frame: From initiation to Week 24 ]
    1. Light to vigorous activity/day, 2. Moderate to vigorous activity/day, 3.Total movement/day, 4.Best 6-minute walk effort
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)
Official Title  ICMJE A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension
Brief Summary The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.
Detailed Description

Rodatristat Ethyl is a peripherally restricted TPH inhibitor being studied as a potential treatment for PAH. This dose-ranging, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effect of Rodatristat Ethyl from baseline on pulmonary vascular resistance as measured at right heart catheterization.

Patients will be enrolled into a main study with an option to enroll into an open label extension.

The study is expected to enroll patients in the USA, Canada and Europe.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Following screening assessments, Patients will be enrolled into 1 of 3 treatment arms in a 1:1:1 randomization.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE
  • Drug: Rodatristat Ethyl 300 mg tablet
    Rodatristat ethyl is a tryptophan hydroxylase (TPH) inhibitor designed to block peripheral serotonin production.
  • Drug: Placebo
    Inactive pill manufactured to mimic rodatristat ethyl
Study Arms  ICMJE
  • Experimental: Rodatristat Ethyl 300 mg BID
    Rodatristat ethyl 300 mg tablet BID + standard of care medication(s) taken for 24 weeks
    Interventions:
    • Drug: Rodatristat Ethyl 300 mg tablet
    • Drug: Placebo
  • Experimental: Rodatristat Ethyl 600 mg BID
    Rodatristat ethyl 600 mg tablet BID + standard of care medication(s) taken for 24 weeks
    Intervention: Drug: Rodatristat Ethyl 300 mg tablet
  • Placebo Comparator: Placebo
    Matching placebo tablet + standard of care medication(s) taken for 24 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2021)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female 18 years or older
  • Body Mass Index (BMI) 18kg/m2 to 38kg/m2
  • Symptomatic PAH belonging to WHO Group 1 on a stable treatment regimen with one or more approved PAH treatments
  • PAH defined as mean pulmonary artery pressure ≥ 20 mmHg during right heart catheterization performed at rest
  • FEV1 ≥ 60 % of predicted normal, FEV1:FVC ratio ≥ 0.70 or TLC ≥ 70% of predicted normal
  • WHO FC II or III

Exclusion Criteria:

  • Pregnant women
  • WHO Pulmonary Hypertension (PH) Group 2 - 5
  • PAH associated with significant venous or capillary involvement (PCWP > 15 mmHg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects (CHD))
  • Three or more risk factors for left ventricular disease; BMI ≥ 30 kg/m^2, diagnosis of essential hypertension that is actively treated, diabetes mellitus, history of significant coronary artery disease, atrial fibrillation, and/or left atrial volume index > 41 mL/m^2
  • Known genetic hypertrophic cardiomyopathy, or cardiac sarcoidosis or amyloidosis
  • The patient has a history of, or currently has, a constrictive cardiomyopathy
  • Known history of any LVEF < 40% by echocardiogram within 3 years of randomization
  • Hemodynamically significant valvular heart disease
  • Patient severely disabled and unable to complete the study
  • End stage renal disease or severe liver disease
  • Known congenital long QT syndrome (LQTS) or known family history of LQTS
  • Depression that is currently rated as severe or recent suicidal behavior or active suicidal ideation with intent to act
  • Uncontrolled arterial hypertension or hypotension
  • Patients currently taking one or more drugs known to prolong the QT interval and which are clearly associated with a known risk of Torsades de Pointe
  • QTcF interval > 450 ms for males or > 470 ms for females
  • Any ECG or clinical laboratory abnormality which precludes safe participation in the study in the opinion of the Investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Watiri Kamau-Kelley +1-408-300-3316 watiri@altavant.com
Contact: Howard Lazarus, MD +1-203-297-5374 howard.lazarus@altavant.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04712669
Other Study ID Numbers  ICMJE RVT-1201-2002 / ELEVATE 2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Altavant Sciences GmbH
Study Sponsor  ICMJE Altavant Sciences GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Altavant Sciences GmbH
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP