An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs

• Register: EUCTR
• Last refreshed on: 9 November 2020
• Main ID: EUCTR2006-000804-18-NL
• Date of registration: 01/12/2006
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics Corporation
• Public title: An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs
• Scientific title: An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT
• Date of first enrolment: 19/06/2007
• Target sample size: 900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000804-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no 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 Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, France, Germany, Ireland, Israel, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Spain, Sweden, United Kingdom

Contacts

• Name: Regulatory Department
• Affiliation: United Therapeutics Europe ltd

• Name: Regulatory Department
• Affiliation: United Therapeutics Europe ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Subject Inclusion Criteria

A subject is eligible for inclusion in this study if all of the following criteria apply:

1. The subject has remained on study drug and completed all assessments during the Treatment Phase of Study TDE-PH-301, TDE-PH-302 or TDE-PH-308.

OR

2.The subject permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301, TDE-PH-302 or TDE-PH-308) due to clinical worsening, completed premature termination assessments prior to discontinuing study drug, and who completed all remaining scheduled study visits AND received placebo during the previous study (TDE-PH-301, TDE-PH-302 or TDE-PH-308).

3. The subject voluntarily gives informed consent to participate in the study.

4. The subject, if a female of childbearding potential must agree to continue practicing an acceptable method of birth control as deemed appropriate by the physician or institution (i.e. surgical sterilization, approved hormonal contraceptives, barrier methods [such as condom or diaphragm] used with a spermicide, an intrauterine device, abstinence, or partner(s) with a vasectomy).


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 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion criteria:
Subject Exclusion Criteria

1. The subject permanently discontinued study drug during the previous study (TDE-PH-301 or TDE-PH-302 or TDE-PH-308) due to treatment related adverse events.

2. The subject permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301, TDE-PH-302 or TDE-PH-308) due to clinical worsening (as defined in those study protocols) and did not undergo premature termination assessments prior to discontinuing study drug, and/or did not complete all remaining study visits through to the final scheduled visit.

3. The subject permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301, TDE-PH-302 or TDE-PH-308) due to clinical worsening, completed premature termination assessments prior to discontinuing study drug, completed all remaining scheduled study visits AND received UT-15C SR during the Treatment Phase of the previous study (TDE-PH-301, TDE-PH-302 or TDE-PH-308).

4. The subject must not have developed any concurrent illness or condition during the conduct of the previous study, including but not restricted to, sleep apnea, chronic renal insufficiency, anemia, uncontrolled systemic hypertension or left-sided heart disease, unless their physician feels that entry into this study would not be detrimental to their overall health.




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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with : 1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 16.0 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-

Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-

Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Treprostinil diethanolamine
CAS Number: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.125-

Primary Outcome(s)

Main Objective: Provide, or continue to provide, UT-15C SR for eligible subjects who participated in protocols TDE-PH-301, TDE-PH-302, TDE-PH-308 or additional UT15C SR clinical protocols.

Secondary Objective: -Assess the long-term safety of UT-15C SR in these subjects through assessment of adverse events and laboratory parameters.

-Assess the effect of continued therapy with UT-15C SR on exercise capacity after one year of treatment.

Timepoint(s) of evaluation of this end point: Adverse events will be reported continuously and clinical laboratory paramenters will be assessed at each study visit.

Primary end point(s): The primary endpoints of the study is adverse events and clinical laboratory parameters.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: A 6-Minute Walk test with Dyspnea Score will be conducted at visit 3, 12 months from the subject's first exposure to UT15C SR. The 6-minute Walk test should be conducted approximately 3 to 6 hours after the morning dose UT15C SR.

Secondary end point(s): Change in 6-Minute Walk Distance after 12 months treatment and Borg Dyspnea Score.

Secondary ID(s)

2006-000804-18-IE

TDE-PH-304

Source(s) of Monetary Support

United Therapeutics Corporation

Ethics review

Status: Approved
Approval date: 19/06/2007
Contact: