Original Primary Outcome: -Safety and tolerability as assessed by. blood pressure, heart rate, ECG, hematology, biochemistry, urinalysis, echocardiography, adverse events and serious adverse events. -Efficacy as measured by an improvement in 6-minute walk test at monthly inter [ Time Frame: 6 months ]

Current Secondary Outcome:

• Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion ]
  PAH assessed according to the WHO classification: Class I Patients with PAH but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PAH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PAH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PAH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.
• Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]
  Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. The test was terminated if the patient became too distressed or if their SaO2% fell below 60%.
• Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]
  Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Systolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test
• Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]
  Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Diastolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test
• Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]
  Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Heart Rate (bpm) were recorded before the test at resting, at the end of the test and two minutes after the end of the test
• Borg Score During the Six Minutes Walk Test at Different Time Periods [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]
  Borg Score during Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Borg Score of Breathlessness was recorded using the following score of 0 to 10, how breathless do you feel? 0 is nothing at all and 10 is maximal breathlessness
• Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion [ Time Frame: Baseline, and Study completion (Week 24) ]
  The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including right Pulmonary Arterial Pressure (PAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.
• Mean Pulmonary A
  
  

  Original Secondary Outcome: - Improvement in clinical status (assessment of WHO class & Borg Score) - Changes in pulmonary hemodynamic parameters - Time to clinical worsening - Changes in plasma biomarker levels [ Time Frame: 6 months ]
  
  Information By: Novartis
  

  Dates:
  Date Received: May 22, 2007
  Date Started: April 2006
  Date Completion:
  Last Updated: March 10, 2015
  Last Verified: March 2015