Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISIO

Phase 1

Conditions: Spanish: hipertensión arterial pulmonar English: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1Classification code 10037400

Registration Number: EUCTR2005-006192-13-ES

Lead Sponsor: CoTherix, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

Patients may be included in the study only if they meet all of the following:
1. Able and willing to give written informed consent and comply with study requirements.
2. Male or female patients aged 18-80 years
3. Have a current diagnosis of symptomatic PAH classified by one of the following: a) IPAH or FPAH; b) PAH associated with one of the following connective tissue diseases and mild or no lung parenchymal disease: scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective tissue disease, c) PAH associated with repaired atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosus (PDA) = 1 year post-operative from Screening, d) PAH associated with HIV, or e) PAH associated with the use of anorexigens (e.g. fenfluramine-phentermine)
4. On a stable dose regimen of sildenafil, at doses between 20 mg TID and 80 mg TID, for at least 12 weeks prior to screening, and tolerating sildenafil without clinically significant side effects
5. Screening 6-MWD of 100-425 meters
6. Have a cardiac catheterization either at baseline or within the previous 3 years consistent with PAH, with the following values: a) mean pulmonary artery pressure (mPAP) at rest > 25 mm Hg, b) pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure = 15 mm Hg, and c) pulmonary vascular resistance (PVR) = 240 dynes·sec·cm-5
7. Have pulmonary function tests showing FEV1/FVC ratio > 50% AND either a) total lung capacity > 70% predicted, or b) total lung capacity between 60% and 70% predicted, with no more than mild patchy interstitial lung disease
8. If HIV-seropositive, must have been stable with a) no concomitant active opportunistic infections and an undetectable viral load for the 6 months prior to screening, b) CD4+ T cell count > 200/mm3 and no change in antiviral regimen for the 3 months prior to screening, c) no change in antiviral regimen anticipated during the course of the study, and d) no use of inhaled pentamidine
9. Documented evidence of absence of thromboembolic disease (i.e., low probability for pulmonary embolism) using methodology such as pulmonary angiogram, ventilation perfusion scan, or chest CT scan within 3 years of screening
10. If on corticosteroids, be receiving a stable dose of = 20 mg/day of prednisone or equivalent for at least 1 month prior to screening
11. Women of childbearing potential must agree to use an adequate method of contraception
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting any of the following criteria are not eligible to participate in the study:
1. Pulmonary arterial hypertension related to any etiology other than those specified in the inclusion criteria (including portopulmonary)
2. Receipt of any prostacyclin or prostacyclin analogue within 12 weeks before screening
3. Receipt of bosentan or other endothelin antagonist within 12 weeks before screening
4. Change in sildenafil dose within 12 weeks before screening
5. Any clinically significant ocular abnormality during screening examination that could be potentially related to sildenafil use (e.g. retinal abnormalities or visual defects)
6. History of poor tolerability to sildenafil
7. Untreated or inadequately treated obstructive sleep apnea
8. History of left-sided heart disease, including any of the following:
- aortic or mitral valve disease;
- pericardial constriction;
- restrictive or congestive cardiomyopathy;
- diastolic dysfunction syndrome;
- left ventricular ejection fraction < 40% by multigated radionucleotide angiogram
(MUGA), angiography, or echocardiography;
- left ventricular shortening fraction < 22% by echocardiography;
- symptomatic coronary disease with demonstrable ischemia;
- life-threatening cardiac arrhythmias
9. Cerebrovascular events (e.g. transient ischemic attack or stroke) within 6 months of screening
10. Chest X-Ray showing medically relevant disease other than findings consistent with PAH
11. Receipt of atrial septostomy within 6 months of screening

12. Any condition other than PAH which might affect the patient’s ability to perform a 6-MWT
13. Clinically relevant obstructive lung disease (e.g. asthma or COPD)
14. Clinically relevant abnormal laboratory values at screening that, in the opinion of the investigator, would compromise the evaluation of efficacy and/or safety of the study drug
15. Treatment with an investigational drug or device which has not received regulatory approval within 120 days before screening
16. Uncontrolled systemic hypertension as evidenced by systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement
17. Systemic hypotension with systolic BP < 95 mmHg
18. Chronic renal insufficiency as defined by a creatinine of > 2.5 mg/dL or the requirement for dialysis
19. Chronic liver disease or cirrhosis, including porto-pulmonary hypertension
20. Clinically relevant bleeding disorder or active bleeding
21. Psychiatric, addictive, or other disorder that compromises the ability to give informed consent for participating in this study
22. Pregnant or breastfeeding
23. The addition or discontinuation of any new type of chronic treatment for PAH including, but not limited to calcium channel blockers within 12 weeks before screening; or vasodilators, digitalis, diuretics, oxygen, or investigational treatments within 30 days before screening; for all of these except diuretics, the dose must have been stable for 7 days prior to baseline. Anti-coagulant therapy may be modified at any time.
24. Concomitant use of medications that are contraindicated with sildenafil, including regular or intermittent use of organic nitrates
25. Are study investigators, study staff, or their immediate families

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Estudio aleatorio, doble-ciego, controlado con placebo que evalúa la seguridad y eficacia de A-60444 en adultos con una infección por el VRS después de un trasplante de células madre.

Phase 1

Arrow Therapeutics Ltd

Updated 8/8/2022

Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIG

Sanofi-aventis Recherche & Développement

Updated 4/24/2012

Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente

Phase 1

GlaxoSmithKline S.A

Updated 10/8/2021

Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato__________________________________________________A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY

Phase 1

Sanofi-aventis Recherche & Développement

Updated 10/8/2021

Estudio aleatorizado , doble-ciego, controlado con placebo, multicéntrico, de fase III, para evaluar la terapia adyuvante con RAD001 frente a placebo, en pacientes con linfoma difuso de células grandes B (LDCGB) de elevado riesgo que hayan alcanzado una respuesta completa tras una primera línea de quimioterapia con rituximab.

Phase 1

ovartis Farmacéutica S.A.

Updated 7/4/2016

Estudio doble ciego, aleatorizado y controlado con placebo, que compara la eficacia y seguridad de dos dosis fijas de un nuevo producto antidepresivo con respecto a placebo en pacientes con trastorno depresivo mayor

H. Lundbeck A/S

Updated 6/12/2012

Estudio doble ciego, aleatorizado y controlado con placebo con grupos paralelos para determinación de dosis de COL-144 por vía oral en el tratamiento agudo de la migraña

Phase 1

CoLucid Pharmaceuticals, Inc.

Updated 10/8/2021

Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis

Phase 1

sanofi-aventis Recherche & Développement

Updated 10/8/2021

Estudio aleatorizado, doble ciego, controlado con placebo, de la seguridad y eficacia de Xyrem® (oxibato sódico) en sujetos con fibromialgia(A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (sodium oxybate) in Subjects with Fibromyalgia)

Jazz Pharmaceuticals, Inc.

Updated 10/16/2012

Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, en el que se evalúa la eficacia y seguridad de tadalafilo (LY450190), administrado una vez al día, en pacientes con disfunción eréctil que no han recibido previamente inhibidores de la PDE5A Randomized, Double-Blind, PLacebo-Controlled, Parallel Study to Assess the Efficacy and Safety of Tadalafil (LY450190) Once a Day in Subjects With Erectile Dysfunction Who Are Naive to PDE5 Inhibitors - LVHX

Phase 1

illy S.A.

Updated 10/8/2021

Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISIO

Recruitment & Eligibility

Study & Design

Related Trials

Estudio aleatorio, doble-ciego, controlado con placebo que evalúa la seguridad y eficacia de A-60444 en adultos con una infección por el VRS después de un trasplante de células madre.

Estudio doble ciego, aleatorizado y controlado con placebo, que compara la eficacia y seguridad de dos dosis fijas de un nuevo producto antidepresivo con respecto a placebo en pacientes con trastorno depresivo mayor

Estudio doble ciego, aleatorizado y controlado con placebo con grupos paralelos para determinación de dosis de COL-144 por vía oral en el tratamiento agudo de la migraña

Estudio aleatorizado, doble ciego, controlado con placebo, de la seguridad y eficacia de Xyrem® (oxibato sódico) en sujetos con fibromialgia(A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (sodium oxybate) in Subjects with Fibromyalgia)

Clinical Trial Alerts

Clinical Trial Alerts