Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)

• Register: EUCTR
• Last refreshed on: 26 October 2020
• Main ID: EUCTR2014-003042-27-HU
• Date of registration: 19/01/2015
• Prospective Registration: Yes
• Primary sponsor: Arena Pharmaceuticals, Inc.
• Public title: Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)
• Scientific title: An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension
• Date of first enrolment: 17/02/2015
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003042-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Bulgaria, Czech Republic, Hungary, Poland, Romania, Serbia, Slovakia, Spain, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Arena Pharmaceutcals Inc.

• Name: Clinical Trial Information Desk
• Affiliation: Arena Pharmaceutcals Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
-Evidence of a personally signed and dated informed consent document
-Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and is deemed an appropriate candidate for participation in a long-term extension study and administration of APD811
-Fulfilled all eligibility criteria for APD811-003 and completed the study as planned
-Patients who discontinued for clinical worsening in APD811-003 and were assigned to placebo and completed all end of study procedures including right heart catheterization (RHC) may participate after their data from the APD811-003 study is cleaned and locked
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion criteria:
-Patients who enrolled in APD811-003 and were withdrawn from study drug treatment due to any AE, SAE, or clinical worsening if assigned to APD811, or patients who did not complete the APD811-003 study for other reasons
-Female patients who wish to become pregnant
-Systolic BP < 90 mmHg at Baseline/Day 1
-Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Pulmonary Arterial Hypertension
MedDRA version: 19.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Code: APD811
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ralinepag
CAS Number: 1187856-49-0
Current Sponsor code: APD811
Other descriptive name: AR392830
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.01-

Product Code: APD811
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ralinepag
CAS Number: 1187856-49-0
Current Sponsor code: APD811
Other descriptive name: AR392830
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.02-

Product Code: APD811
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ralinepag
CAS Number: 1187856-49-0
Current Sponsor code: APD811
Other descriptive name: AR392830
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.03-

Product Code: APD811
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ralinepag
CAS Number: 1187856-49-0
Current Sponsor code: APD811
Other descriptive name: AR392830
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.04-

Product Code: APD811
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ralinepag
CAS Number: 1187856-49-0
Current Sponsor code: APD811
Other descriptive name: AR392830
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1-

Primary Outcome(s)

Main Objective: Primary:
To evaluate the long-term safety and tolerability of APD811 in patients with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH) who have completed the APD811-003 study

Timepoint(s) of evaluation of this end point: Safety Assessments:
-Clinical laboratory tests (to include hematology, coagulation parameters (PT/PTT, INR), serum chemistry, and urinalysis)
-Vital signs
-Physical examinations
-12-lead electrocardiograms (ECGs)
-Adverse events
The schedule of procedures is different for APD811-003 patients treated with APD811 and entering APD811-007 and APD811-003 patients treated with Placebo and entering APD811-007 (see Table 1 and Table 2 in protocol APD811-007)

Secondary Objective: Secondary:
-To evaluate the effect of APD811 in patients with WHO Group 1 PAH who completed the APD811-003 study, as determined by the incidence of clinical worsening.
-In patients with WHO Group 1 PAH who have completed the APD811-003 study, to evaluate changes from baseline in the following efficacy endpoints with APD811 treatment:
*6 minute walk distance (MWD)
*WHO/NYHA FC

Primary end point(s): The primary endpoint for the study is long-term safety. The safety of APD811 will be monitored throughout the study with safety endpoints being as follows:
-Treatment-emergent adverse events (AEs) up to 28 days following discontinuation of the study drug
-Treatment-emergent serious adverse events (SAEs) up to 28 days following discontinuation of the study drug

Secondary Outcome(s)

Secondary end point(s): Efficacy Endpoints:
Assessment of time to clinical worsening (TTCW) and change from Baseline in APD811-003 in the following:
-6 minute walk distance (MWD)
-WHO/NYHA FC

Timepoint(s) of evaluation of this end point: The schedule of procedures is different for APD811-003 patients treated with APD811 and entering APD811-007 and APD811-003 patients treated with Placebo and entering APD811-007 (see Table 1 and Table 2) in protocol APD811-007)

Secondary ID(s)

2014-003042-27-CZ

APD811-007

Source(s) of Monetary Support

Arena Pharmaceuticals, Inc.

Ethics review

Status: Approved
Approval date: 10/02/2015
Contact: