Trial record 11 of 1335 for:    hypertension | Open Studies | Exclude Unknown

Tadalafil for Sarcoidosis Associated Pulmonary Hypertension (SAPH)

This study is currently recruiting participants.
Verified April 2013 by University of North Carolina, Chapel Hill
Sponsor:
Collaborators:
Eli Lilly and Company
United Therapeutics
Information provided by (Responsible Party):
Hubert M. Ford, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01324999
First received: March 24, 2011
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

This study is designed to assess the efficacy and safety of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension.

Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis


Condition Intervention Phase
Pulmonary Hypertension
Drug: Tadalafil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in 6 minute walk distance [ Time Frame: 5 months of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sarcoidosis Associated Pulmonary Hypertension
Sarcoidosis Associated Pulmonary Hypertension
Drug: Tadalafil
20mg/day for one month then 40mg/day for additional 4 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven sarcoidosis
  • Mean pulmonary artery pressure > 25 mmHg at rest or greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study
  • Pulmonary capillary wedge pressure ≤ 15 mmHg
  • PVR values ≥ 3.0 Woods units
  • Forced vital capacity (FVC) > 40% predicted
  • Forced expiratory volume in 1 second (FEV1) > 40% predicted
  • WHO functional class II or III
  • Stable sarcoidosis treatment regimen for three months prior to entry into study
  • 6 minute walk distance between 150-450 meters
  • Stable dose of antihypertensive medications
  • On no other medication to treat PAH (sildenafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, ambrisentan) within one month prior to enrollment and during duration of the study
  • Non-pregnant females

Exclusion Criteria:

  • Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
  • Severe systemic hypertension > 170/95
  • Severe systemic hypotension < 90/50
  • History of priapism
  • Patients with congestive heart failure (left ventricular dysfunction) LVEF < 45% by echocardiogram
  • Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
  • Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, chronic thromboemboli)
  • Use within 1 month of an sildenafil or vardenafil
  • WHO functional class IV status
  • Patients with severe other organ disease felt by investigators to impact on survival during the course of the study
  • Subjects with liver function abnormalities (ALT or AST > 3 times the upper limit of normal at screening or at baseline) or chronic liver disease
  • Advanced kidney failure (GFR < 30 ml/min at screening or at baseline)
  • History of hypersensitivity reaction or adverse effect related to tadalafil
  • Pregnant or lactating women
  • Concomitant use of nitrates (any form) either regularly or intermittently
  • Concomitant use of potent CYP3A inhibitors (eg, ritonavir, ketoconazole, itraconazole)
  • Any additional contraindications and precautions specified in the package inserts for Tadalafil (Adcirca) not listed above
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324999

Contacts
Contact: Hubert J Ford, MD 919-966-2531 hjford@med.unc.edu
Contact: Sharikia J Burt, MS 919-966-2531 sburt99@med.unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Hubert J Ford, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eli Lilly and Company
United Therapeutics
Investigators
Principal Investigator: Hubert J Ford, M.D. University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Hubert M. Ford, MD, Assistant Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01324999     History of Changes
Other Study ID Numbers: 09-2326
Study First Received: March 24, 2011
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Sarcoidosis Associated Pulmonary Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Sarcoidosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Tadalafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014