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Clinical Trials: Stride 2
Protocol: STRIDE 2
Title:
A Phase III, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment with an Open-label Bosentan Arm in Patients with Pulmonary Arterial Hypertension (PAH)
Purpose:
The purpose of this study is to evaluate the safety and efficacy of Thelin™ as compared to placebo in the treatment of patients with PAH. A cohort of patients will be randomized to usual treatment with bosentan for observational comparisons of safety and efficacy.
Sponsor:
Encysive Pharmaceuticals
Number of subjects to be enrolled:
240
Inclusion Criteria
1. Have a current diagnosis of symptomatic PAH classified by one of the following:
(a) primary pulmonary hypertension (PPH) - also known as idiopathic pulmonary arterial hypertension (IPAH);
(b) PAH associated with connective tissue diseases:
(c) PAH associated with one of the following congenital heart defects:
• repaired ASD, VSD or PDA greater than or equal to 1year post-operative
• un-repaired secundum ASD (with resting O2 saturation greater than or equal to 88% in room air measured by oximeter)
2. World Health Organization (WHO) functional class II, III or IV.
3. greater than or equal to 12 and less than or equal to 75 years of age.
4. Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)
5. Have a cardiac catheterization within 6 months before study entry that shows the following values:
• mean pulmonary artery pressure (PAPm) greater than 25 mmHg (at rest),
• pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure less than or equal to 15 mmHg, and
• pulmonary vascular resistance (PVR) greather than or equal to 3 mmHg/L/min.
Exclusion Criteria
1. Portal hypertension or chronic liver disease.
2. ALT or AST levels greater than 1.5 times the upper limit of normal at the Screening Visit
3. Contraindication to treatment with an endothelin receptor antagonist
4. Recent history of abusing alcohol or illicit drugs
5. Chronic renal insufficiency
6. Pregnant or breastfeeding
7. Atrial septostomy within 30 days before study entry
8. Previous failure on bosentan because of safety concerns or the lack of clinical response
Description:
This is a multi-center, randomized, double-blind, placebo-controlled study of Thelin™ given orally to patients with PAH. Patients will be randomized to receive one of four treatments (placebo once daily, Thelin™ 50 mg once daily, or Thelin™ 100 mg once daily; or bosentan twice daily according to the Package Insert).
Duration:
18 weeks
Enrollment into a long term extension trial is available
Contact
Pablo Garces, M.D.
1-800-804-1593
see also : http://www.phassociation.org/clinical_trials/
Protocol: FPH03
Title:
A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium (Thelin™) Treatment in Patients with Pulmonary Arterial Hypertension.
Purpose:
The purpose of this study is to evaluate the long-term safety of the endothelin receptor antagonist Thelin™ in patients with pulmonary arterial hypertension.
Sponsor:
Encysive Pharmaceuticals
Number of subjects to be enrolled:
~300
Inclusion Criteria
1. currently receiving Thelin™ though compassionate use (either through an investigator IND or protocol FPH01-XC)
2. successfully completed protocol FPH02, FPH02-X, FPH04 or FPH06
3. were actively enrolled in TBC11251-211X or FPH01-X (STRIDE-I Extension) and were required to discontinue Thelin™ treatment due to closure of the protocol
4. met inclusion/exclusion criteria for Protocol FPH02 or Protocol FPH04, except for:
a. having walked greather than 450 meters at the Baseline 6-minute walk assessment;
b. WHO functional class of I;
c. PAH associated with congenital heart defects; or,
d. PAH associated with sleep apnea
Exclusion Criteria
1. Treatment with an investigational drug or device which has not received regulatory approval, other than Thelin™, within 30 days before study entry.
2. HIV infection under treatment with, or anticipated need for, HIV therapy metabolized by a cytochrome P450 enzyme
3. ALT or AST levels greater than 1.5 times the upper limit of normal at the Screening Visit
4. Chronic renal insufficiency
5. Pregnant or breastfeeding
6. Need for, or anticipated need for, chronic treatment with phosphodiesterase inhibitor (e.g., Viagra®) for the treatment of pulmonary hypertension.
Description:
This is a multi-center, open-label study of Thelin™. Patients will receive Thelin™ 100 mg taken orally, once daily for up to 52 weeks.
Duration:
52 weeks
Contact
Pablo Garces, M.D.
1-800-804-1593
Protocol: FPH06
Title:
A Double-Blind Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients with Pulmonary Arterial Hypertension Who Have Failed Bosentan Therapy
Purpose:
The purpose of this study is to evaluate the safety and efficacy of sitaxsentan sodium in patients with PAH who have failed treatment with standard dose bosentan (Tracleer™), or who have been discontinued from bosentan treatment due to safety issues.
Sponsor:
Encysive Pharmaceuticals
Number of subjects to be enrolled:
~40
Inclusion Criteria
1. Have a current diagnosis of symptomatic PAH classified by one of the following:
• primary pulmonary hypertension (PPH) — also known as idiopathic pulmonary arterial hypertension (IPAH);
• PAH associated with connective tissue diseases:
• PAH associated with congenital heart defects, repaired or unrepaired.
2. World Health Organization (WHO) functional class I, II, III or IV
3. greater than or equal to 12 and less than or equal to 75 years of age.
• with the exception of patients treated in Canada, who must be greather than or equal to 16 and less than or equal to 75 years of age
4. Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)
5. Diagnosed with PAH via right cardiac catheterization that showed the following values prior to bosentan therapy:
• mean pulmonary artery pressure (PAPm) greater than 25 mmHg (at rest),
• pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure less than or equal to 15 mmHg, and
• pulmonary vascular resistance (PVR) greather than or equal to 3 mmHg/L/min.
6. Have failed standard dose bosentan therapy (greather than 6 weeks of therapy) either due to lack of clinical response by Investigator's judgment, or due to safety concerns/dose limiting toxicity.
Exclusion Criteria
1. Portal hypertension or chronic liver disease
2. No evidence of thromboembolic disease
3. Inability to perform 6-minute walk test
4. ALT or AST levels greater than 1.5 times the upper limit of normal at the Screening Visit
5. Recent history of abusing alcohol or illicit drugs
6. Chronic renal insufficiency
7. Pregnant or breastfeeding
8. Treatment with an investigational drug or device, which has not received regulatory approval, within 30 days before study entry
9. Receipt of any chronic prostacyclin, prostacyclin analogue, ET receptor antagonist (except bosentan), or phosphodiesterase inhibitor therapy within 14 days before study entry
Description:
This is a multi-center, randomized, double-blind study of different doses of sitaxsentan given orally to patients with PAH that have failed bosentan therapy. Patients will receive sitaxsentan 50 mg or 100 mg taken orally, once daily for up to 12 weeks.
Duration:
12 weeks
Enrollment into a long term extension trial is available
Contact
Pablo Garces, M.D.
1-800-804-1593
see also : http://www.phassociation.org/clinical_trials/
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