Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lung Rx
ClinicalTrials.gov Identifier:
NCT00990314
First received: October 5, 2009
Last updated: May 19, 2014
Last verified: May 2014

October 5, 2009
May 19, 2014
November 2009
November 2013   (final data collection date for primary outcome measure)
Safety will be assessed by adverse events, physical examination, vital signs, clinical laboratory parameters, and electrocardiogram findings. [ Time Frame: 3, 6 & 12 months & annually thereafter ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00990314 on ClinicalTrials.gov Archive Site
  • Unencouraged 6-Minute Walk Test (6MWT) [ Time Frame: 3, 6 & 12 months & annually thereafter ] [ Designated as safety issue: No ]
  • Clinical Worsening [ Time Frame: 3, 6 & 12 months & annually thereafter ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients
An Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients

This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release (BPS-MR) tablets.

Eligible patients who participated in BPS-MR-PAH-203 and who elect to continue receiving study drug in an open-label extension.Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment. Patients will be called by study personnel to assess adverse events and concomitant medications at Month 9, and at 3 month intervals following the annual visit.

At the End of Study visit, patients discontinuing study drug will be down-titrated off of BPS-MR at the discretion of the Investigator, at a maximum decrement of one tablet (60µg) b.i.d. per day and a minimum decrement of one tablet (60µg) b.i.d. per week. Likewise, patients who withdraw early from the study will be down-titrated off of BPS-MR in the same manner. Upon completion of down-titration, patients will return to the clinic for a final Closeout visit.

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-204 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, 60mcg
  • Beraprost Sodium Modified Release Tablet, 60mcg
  • Experimental: B.I.D
    Beraprost Sodium Modified Release Tablet, 60mcg, B.I.D (twice a day dosing)
    Intervention: Drug: Beraprost Sodium Modified Release
  • Experimental: Q.I.D
    Beraprost Sodium Modified Release Tablet, 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
31
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 203 are eligible for this study.
  • Women of child-bearing potential (defined as less than 1 year post-menopausal or not surgically sterile) must be using an acceptable method of birth control or practicing abstinence. If sexually active, female patients must use a double barrier method of birth control, such as a condom and spermicidal.

Exclusion Criteria:

  • Patients who discontinued study drug during the previous study (BPS MR PAH 203) 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,   Czech Republic,   Germany,   Ireland,   Romania
 
NCT00990314
BPS-MR-PAH-204
No
Lung Rx
Lung Rx
Not Provided
Study Director: Aimee Smart Study Sponsor
Lung Rx
May 2014

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