An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lung Biotechnology Inc.
ClinicalTrials.gov Identifier:
NCT00792571
First received: November 14, 2008
Last updated: May 19, 2014
Last verified: May 2014

November 14, 2008
May 19, 2014
February 2009
November 2013   (final data collection date for primary outcome measure)
The primary outcome is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in BPS-MR-PAH-201 study [ Time Frame: In order to evaluate the long-term safety and efficacy of BPS-MR, the study is expected to continue until the first of either of the following is reached: December 31, 2014 or LungRx discontinues the project. ] [ Designated as safety issue: Yes ]
The primary objective is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in the BPS-MR-PAH-201 study. [ Time Frame: Until the commercial product is available for purchase in the appropriate region or Lung Rx discontinues the project. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00792571 on ClinicalTrials.gov Archive Site
The secondary objectives are to describe the efficacy of BPS-MR tablets on an unencouraged 6-Minute Walk Test, the Borg Dyspnea Scale and Clinical Worsening in eligible patients who participated in the BPS-MR-PAH-201 study. [ Time Frame: In order to evaluate the long-term safety and efficacy of BPS-MR, the study is expected to continue until the first of either of the following is reached: December 31, 2014 or LungRx discontinues the project. ] [ Designated as safety issue: Yes ]
The secondary objectives are to describe the efficacy of BPS-MR tablets on an unencouraged 6-Minute Walk Test, the Borg Dyspnea Scale and Clinical Worsening in eligible patients who participated in the BPS-MR-PAH-201 study. [ Time Frame: Until the commercial product is available for purchase in the appropriate region or Lung Rx discontinues the project. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.

This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.

This is an open-label study for patients who participated in the BPS-MR-PAH-201 study and have volunteered to continue treatment for PAH with BPS-MR tablets. Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment.

Currently enrolled patients may be invited to participate in an optional four times daily (QID) dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the main study. Patients will return to the clinic for baseline visit, week 12, and then will follow the visit schedule provided to them in BPS-MR-PAH-202 main study.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: Beraprost Sodium Modified Release
Other Names:
  • BPS-MR Tablets, 60 mcg
  • Beraprost Sodium Modified Release Tablet, 60 mcg
  • Experimental: B.I.D
    Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing)
    Intervention: Drug: Beraprost Sodium Modified Release
  • Experimental: Q.I.D
    Beraprost Sodium Modified Release Tablets, 60mcg, q.i.d (four times a day dosing)
    Intervention: Drug: Beraprost Sodium Modified Release
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who remained on study drug and completed all assessments during the Treatment Phase of Study BPS-MR-PAH-201 are eligible for this study.
  • Female patients must either be physiologically incapable of childbearing or be practicing an acceptable method of birth control (e.g. approved hormonal contraceptive, barrier method, such as condom or diaphragm, used with a spermicide, or an intrauterine device).

Exclusion Criteria:

  • Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) for any reason (e.g. treatment related adverse events) are not eligible for entry into this study.
  • Patients who are pregnant or lactating are excluded from participation in the open-label extension.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Ireland
 
NCT00792571
BPS-MR-PAH-202
No
Lung Biotechnology Inc.
Lung Biotechnology Inc.
Not Provided
Study Director: Aimee Smart Study Sponsor
Lung Biotechnology Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP