International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia: Extension to Studies 156-02-235 and 156-03-238 to Assess One-year Safety

International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia

Sponsors

Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Brief Summary

This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and underlying disease states.

Overall Status Completed
Start Date May 2004
Completion Date October 2009
Primary Completion Date October 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Participants With Adverse Events (AEs) Baseline to Post-Week 214 follow-up visit
Participants With Laboratory Values Abnormalities Reported as TEAEs Baseline to Post-Week 214 follow-up visit
Participants With Electrocardiogram (ECG) Related Abnormalities Reported as TEAEs Baseline to Post-Week 214 follow-up visit
Participants With Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs) Baseline to Post-Week 214 follow-up visit
Participants With Body Weight Abnormalities Reported as TEAEs Baseline to Post-Week 214 follow-up visit
Secondary Outcome
Measure Time Frame
Mean Change From Baseline in Serum Sodium Measurements Baseline of parent trial to Week 214
Change From Baseline in Percentage of Participants With Severe Hyponatremia Baseline to Week 214
Change From Baseline in Percentage of Participants With Mild Hyponatremia Baseline to Week 214
Change From Baseline in Percentage of Participants With Normal Sodium Levels Baseline to Week 214
Percentage of Participants Requiring Prescription of Fluid Restriction Baseline to Post-Week 214 follow-up visit
Number of Participants Requiring Prescription of Hypertonic Saline Baseline to Post-Week 214 follow-up visit
Percentage of Participants Requiring Prescription of Other Medicines Baseline to Post-Week 214 follow-up visit
Mean Change From Baseline in Body Weight by Visit for Those Participants Who Had Clinical Evidence of Hypervolemia at Baseline Baseline to Week 214
Mean Change From Baseline in SF-12 (Health Survey) Physical Component Summary (PCS) Baseline to Week 214
Mean Change From Baseline in SF-12 (Health Survey) Mental Component Summary (MCS) Baseline to Week 214
Change From Baseline in the Hyponatremia Disease-specific Survey Baseline to Week 214
Enrollment 111
Condition
Intervention

Intervention type: Drug

Intervention name: Tolvaptan

Description: Once Daily

Arm group label: Tolvaptan

Eligibility

Criteria:

Inclusion Criteria:

1. Age greater than or equal to 18 years.

2. Ability to provide informed consent or assent.

3. Prior successful participation in a tolvaptan hyponatremia trial termination with evidence of continued need or desire for therapy.

Exclusion Criteria:

- A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient.

- Hyponatremia which is acute, reversible, artifactual or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy.

- Hyponatremia due to reversible medical condition or therapy

- Conditions associated with an independent imminent risk of morbidity and mortality

- Conditions which confound the assessment of endpoints.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Verification Date

December 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Tolvaptan

Arm group type: Experimental

Description: Enrolled subjects began treatment with 15 mg tolvaptan QD. A titration between target doses of 15 mg, 30 mg, or 60 mg of trial medication was based on the subject's change in serum sodium concentration and clinical tolerance of the trial medication.

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov