Pulmonary HypertensionPhase 3NCT00080457
Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension
A Phase 3 study testing sitaxsentan sodium in people with Pulmonary Hypertension, run by Encysive Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (PAH). Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- sitaxsentan sodium
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 one of the following congenital heart defects:
- repaired ASD, VSD or PDA greater than one year post-operative
- un-repaired secundum ASD (with resting oxygen saturation greater than 88 percent in room air measured by oximeter)
Show all 13Show fewer
- World Health Organization (WHO) functional class II, III, IV
- Greater than 12 and less than 75 years of age
- Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)
- 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 15 mmHg, and
- pulmonary vascular resistance (PVR) greater than 3 mmHg/L/min.
Who cannot join
- Portal hypertension or chronic liver disease
- ALT or AST levels greater than 1.5 times the upper limit of normal at the Screening Visit
- Contraindication to treatment with an endothelin receptor antagonist
- Recent history of abusing alcohol or illicit drugs
- Chronic renal insufficiency
- Pregnant or breastfeeding
- Atrial septostomy within 30 days before study entry
- Previous failure on bosentan because of safety concerns of the lack of clinical response
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, 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)
The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (PAH).
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) as compared to placebo in the treatment of patients with PAH. A cohort of patients will be randomized to usual treatment with Tracleer® (bosentan) for observational comparisons of safety and efficacy.
- Conditions
- Pulmonary Hypertension
- Being tested
- sitaxsentan sodium
- Keywords
- Primary or secondary pulmonary arterial hypertension, Scleroderma, Connective tissue disease, Congenital heart defects, Lupus, Pulmonary Arterial Hypertension
- Medical subject headings
- Hypertension, Pulmonary, Scleroderma, Diffuse, Connective Tissue Diseases, Heart Defects, Congenital, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitaxsentan sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2004 (estimated)
- Study startMay 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Encysive Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080457
- Sponsor's protocol ID
- STRIDE 2
- Status last verified
- Nov 2007
- First submitted
- 1 Apr 2004
- Last updated
- 9 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 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)
- ClinicalTrials.gov ID
- NCT00080457
- Acronym / sponsor ID
- STRIDE 2
- Conditions
- Pulmonary Hypertension
- Keywords
- Primary or secondary pulmonary arterial hypertension, Scleroderma, Connective tissue disease, Congenital heart defects, Lupus, Pulmonary Arterial Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Encysive PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Jan 2005 (actual)
- First posted
- 5 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (PAH).
Detailed description
The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) as compared to placebo in the treatment of patients with PAH. A cohort of patients will be randomized to usual treatment with Tracleer® (bosentan) for observational comparisons of safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Have a current diagnosis of symptomatic PAH classified by one of the following:
- World Health Organization (WHO) functional class II, III, IV
- Greater than 12 and less than 75 years of age
- Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)
- Have a cardiac catheterization within 6 months before study entry that shows the following values:
Key exclusion criteria (8 listed)
- Portal hypertension or chronic liver disease
- ALT or AST levels greater than 1.5 times the upper limit of normal at the Screening Visit
- Contraindication to treatment with an endothelin receptor antagonist
- Recent history of abusing alcohol or illicit drugs
- Chronic renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sitaxsentan sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sitaxsentan sodium in people with Pulmonary Hypertension, run by Encysive Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2007.