Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.

NCT00705588 | Unknown Phase 4

• 1 other identifier: RMC084936CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in constriction and high pressures. Treatment is given with a variety of drugs including the prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors (e.g. sildenafil). Although these drugs are known to be effective alone, little is known about combining them together in various combinations. In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with pulmonary arterial hypertension who currently are receiving only a prostanoid drug.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• Six minute walking distance

  12 weeks

• Level of pro-NT BNP

  12 weeks

Secondary Outcomes (2)

• Echo-derived parameters

  12 weeks

• Cardiopulmonary exercise test

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).

Drug: Tadalafil

2

EXPERIMENTAL

Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)

Drug: Vardenafil

Interventions

Tadalafil DRUG

Orally, titrated to maximum 20mg od

Also known as: Cialis

1

Vardenafil DRUG

Orally, titrated to 10 mg bid

Also known as: Levitra

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 3 years of study enrollment): Mean PAP \>25mmHg at rest or \>30mmHg with exercise, by a PCWP\< 15mmHg and by PVR \>3 Wood Units.
• Currently stable for at least 3 months on prostanoid monotherapy (epoprostenol iv or iloprost inhaled).
• Willing and able to participate in all study follow-up procedures.
• New York Heart Association (NYHA) Class II-IV.
• Six minute walking distance between 100-450 meters at the baseline assessment.
• Women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.

You may not qualify if:

• Functional Class NYHA Class I.
• PAH due to chronic pulmonary thromboembolic disease, left heart disease, chronic lung diseases (VC or FEV1 \< 60% of predicted) or chronic hypoxia.
• Acute intercurrent illness requiring hospital admission in the month proceeding screening.
• Any non-PAH medical condition likely to interfere with participation in evaluation of study endpoints, e.g. musculoskeletal disorders.
• Any uncontrolled or terminal non-PAH medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
• Concomitant therapy with drugs known to interact adversely with the study drug.
• Chronic renal failure - creatinine clearance \<50ml/min as calculated with the Cockcroft equation.
• Current participation in another clinical trial.
• Pregnancy or planned pregnancy during the study period.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Pulmonary Institute, Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Tadalafil; Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Imidazoles; Azoles; Piperazines

Study Officials

• Mordechai R Kramer, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mordechai R Kramer, MD

CONTACT

972-3-937-7221; kremerm@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 26, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2010
• Last Updated: June 26, 2008

Record last verified: 2008-05

Locations

IL (1)