Aviptadil and placebo in patients with pulmonary hypertension.

• Research type

  Research Study

• Full title

  Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension

• Sponsor organisation

  MondoGen

• Eudract number

  2007-003621-24

• Research summary

  Pulmonary arterial hypertension (PAH) is a potentially fatal condition, in which the arteries of the right side of the heart, which supply blood to the lungs, become narrow or blocked and are unable to supply sufficient oxygenated blood to the lungs for normal activity. There are a number of treatments for the condition, some of which may be used in combination, but there is currently no cure.This study will assess the clinical efficacy and safety of a naturally occurring peptide called vasointestinal peptide, which has already been shown to be beneficial in pilot studies.48 adult patients between 18 and 80 years of age in approximately 14 centres in Europe and the US will be enrolled in this study. Patients will throughout the study continue to receive a stabilized therapy of drugs which they would normally take for PAH. The study will comprise two phases, an acute phase, in which patients will receive one of three single doses of study drug, or placebo, and a chronic phase, in which patients will continue to receive the same dose for a minimum of 12 weeks or a maximum of 52 weeks, depending on when they are enrolled into the study.During the acute phase the patient??s heart function will be closely monitored whilst undergoing a catheterization procedure and during the chronic phase the patient??s general health and ability to undergo exercise will be closely monitored during visits to the clinic at regular intervals.It is hoped that the study will demonstrate that aviptadil can cause a reduction of the pressure in the blood vessels of the lung circulation which will result in an improvement in the patient??s exercise tolerance as demonstrated by the distance the patient is able to walk comfortably during a six minute period. It is hoped also to demonstrate that the treatment is safe and well tolerated.

• REC name

  West of Scotland REC 1

• REC reference

  08/S0703/117

• Date of REC Opinion

  2 Dec 2008

• REC opinion

  Further Information Favourable Opinion