A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension.
- Conditions
- increases blood pressure in the pulmonary circulation10037454
- Registration Number
- NL-OMON51446
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 4
History of PAH belonging to one of the following subgroups of the Clinical
Classification Group 1 (WHO):
- Participants with idiopathic pulmonary arterial hypertension (IPAH)
- Hereditary pulmonary arterial hypertension
- Congenital heart disease (surgically repaired at least 12 months prior to
screening)
- drug or toxin induced (for example, anorexigen, or methamphetamine use).
-Resting mean pulmonary arterial pressure (mPAP) > 25 mmHg; pulmonary capillary
wedge pressure (PCWP) or left ventricular end diastolic pressure < 15 mmHg, as
determined by right
heart catheterization within 20 days of randomization.
- Pulmonary Vascular Resistance > 6 Wood units (480 dynes s/cm-5), as
determined by right heart catheterization within 20 days of randomization.
- WHO Functional Class II-III
- 6MWD must be between 150 and 550 m (inclusive). The qualifying test needs to
be within 20 days of randomization. To meet the above criterion additional six
minute walk test (6MWT) may be performed up to a maximum of 3 tests in total
prior to dosing; the minimal time difference between two tests should be at
least 4 h.
- Standard of care therapy which is stable at least 6 weeks prior to RHC and
qualifying 6MWT assessment within 20 days of randomization.
- Participants with pulmonary hypertension (PH) in the Clinical Classification
Groups 2-5 (WHO), and any PAH Group 1 subgroups not covered by Inclusion
Criterion #4.
- Participants with a history of left sided heart disease, chronic left sided
heart failure, congenital or acquired valvular disease compromising left
ventricular function and/or pulmonary venous hypertension or symptomatic
coronary disease
- Participants with obstructive lung disease defined as: FEV1/FVC < 60% and
FEV1 < 60% of predicted value after bronchodilator administration as well as
participants with moderate or severe
restrictive lung disease: Total Lung Capacity < 70% of predicted value.
- Acute or chronic impairment (other than dyspnea), which would limit the
ability to comply with study requirements, including interference with physical
activity and execution of study procedures such as 6MWT (e.g., angina pectoris,
claudication, musculoskeletal disorder, multiple
sclerosis, need for walking aids).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PVR, pulmonaire vasculaire resistance at week 25 in participants treated with<br /><br>LTP001 compared to placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the effect of LTP001 on:<br /><br>* Six Minute Walk Distance (6MWD)<br /><br>* Hemodynamic parameters other than PVR<br /><br>* Measurements of right ventricular function<br /><br><br /><br>To assess the impact of LTP001 on:<br /><br>* patient reported outcomes (PRO).<br /><br>* Time to Clinical Worsening (TTCW)<br /><br>* The N-terminal fragment of the prohormone B-type natriuetic peptide<br /><br>(NT-proBNP)<br /><br><br /><br>To assess the safety and tolerability of LTP001<br /><br>* To investigate the pharmacokinetics (PK) of LTP001</p><br>