A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2005-002844-24-GB
• Date of registration: 12/09/2005
• Prospective Registration: Yes
• Primary sponsor: Lilly ICOS LLC
• Public title: A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX
• Scientific title: A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX
• Date of first enrolment: 10/04/2006
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002844-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; 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): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Germany, Ireland, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
- For purposes of study entry, clinical worsening is defined as WHO functional class deterioration and documentation of clinical worsening. The following subjects will be eligible to enter the extension trial.
• The subject discontinues the placebo-controlled study (LVGY) due to clinical worsening and is on placebo, tadalafil 2.5 mg, 10 mg, or 20 mg, or
• The subject completes Week 16 in the placebo-controlled study (LVGY), and has one of the following:
• No clinical worsening.
• Clinical worsening at the Week 16 visit and is receiving placebo, tadalafil 2.5mg, 10 mg, or 20 mg.
- A female subject of childbearing potential must have a negative serum pregnancy test at the screening visit and agree to use two medically reliable methods of contraception (e.g., barrier with spermacide or hormonal contraception) until study completion.
- Written informed consent (and written assent for minors) will be obtained prior to any study procedure being performed.

Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Are nursing or pregnant.
- Have left-sided heart disease, including any of the following:
clinically significant aortic or mitral valve disease (i.e., aortic stenosis, aortic insufficiency, mitral stenosis, moderate or greater mitral regurgitation); pericardial constriction; restrictive or congestive cardiomyopathy; left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography; left ventricular shortening fraction < 22% by echocardiography; life-threatening cardiac arrhythmias; symptomatic coronary artery disease within 5 years of study entry.
- Have a systolic blood pressure < 90 mm Hg or diastolic blood pressure < 50 mm Hg at screening.
- Have a history of angina pectoris or other condition that was treated with long-or short-acting nitrates within 12 weeks before administration of study drug.
- Have a musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease besides pulmonary arterial hypertension that may significantly limit ambulation.
- Current treatment with antiretroviral therapy (protease inhibitor), ketoconazole, or
itraconazole.
- Current treatment with a prostacyclin or analogue, L-arginine, phosphodiesterase inhibitor other than tadalafil, or investigational drug.
- Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Are employed by Lilly or ICOS (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or ICOS employees may participate in Lilly ICOS LLC-sponsored clinical trials, but are not permitted to participate at a Lilly or ICOS facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.



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

Health Condition(s) or Problem(s) studied

Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.

Intervention(s)

Product Name: Cialis
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tadalafil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20 -

Primary Outcome(s)

Primary end point(s): Six-minute walk distance and time to WHO functional class deterioration from Day 0 to Week 52.

Secondary Objective: To determine the durability of efficacy of tadalafil 20 mg and 40 mg once daily in the treatment of patients with PAH.

Main Objective: To evaluate the long-term safety and efficacy of tadalafil 20 mg and 40 mg once daily in the treatment of patients with PAH.

Secondary ID(s)

H6D-MC-LVGX

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 04/01/2017
• Date Completed: 27/02/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-002844-24/results