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OpenTrials
Completed

NCT Number: NCT00478192

Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia

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Key information

Conditions

Hyponatremia Edema Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Coimbatore, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Euvolemic or hypervolemic (edematous) based on clinical presentation
  • Serum sodium between 115 and 130mEq/L at baseline

Exclusion criteria

  • Clinical presentation of volume depletion or dehydration

Treatment and study plan

conivaptan

Drug

premix bag

Other names: YM087, Vaprisol

Placebo

Drug

premix bag

Primary outcomes

  1. Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.

    Time frame: Baseline and 48 hours

    Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.

    Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.

    Change is calculated as Hour 48 - Baseline.

Secondary outcomes

  1. Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment

    Time frame: Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48

    Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.

    Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.

    Change is calculated as Actual Data for each time point - Baseline

  2. Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium

    Time frame: 48 Hours

    Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.

    The endpoint was not evaluable in the placebo arm (median and interquartile range cannot be estimated) or the conivaptan QD arm (interquartile range cannot be estimated) because too high a percentage of patients were censored for the event. Only the conivaptan BID arm will be reported.

  3. Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours

    Time frame: 48 Hours

    Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.

  4. Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours

    Time frame: 48 Hours

    Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >6 mEq/L or two consecutive measurements >135 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.

  5. Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours

    Time frame: 48 Hours

    Each individual subject's change from baseline serum sodium levels was used to calculate baseline adjusted area under the curve serum sodium levels for a duration of Time 0 to Time t in hours (labeled as AUC(Na)(0-t). The last available serum sodium level prior to dosing on Day 1 was used as baseline.

    "t"=48 Hours

  6. Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment

    Time frame: Baseline, Hour 12, Hour 24,Hour 36 and Hour 48

    Effective water clearence (EWC) was calculated as EWC=V(1-(Una+Uk)/(Pna+Pk)), where V is urine volume, Una is the urine sodium concentration, Uk is the urine potassium concentration, Pna is the serum/plasma sodium concentration, an Pk is the serum /plasma potassium concentration.

    Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.

    Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.

    Change is calculated as Actual Data for each time point - Baseline

  7. Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment

    Time frame: Baseline, Hour 24 and Hour 48

    Free water clearance (FWC) was calculated as FWC=V(1-Uosm/Posm), where V is urine volume, Uosm is the urine osmolality, Posm is the plasma sodium osmolality.

    Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.

    Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.

    Change is calculated as Actual Data for each time point - Baseline

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study title

A Phase IIIb, Randomized, Double-Blind, Parallel Group, Multi-Center, Study to Assess the Efficacy and Safety of Multiple 30 Minute Infusions of YM087 (Conivaptan) in Subjects With Euvolemic or Hypervolemic Hyponatremia

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 24, 2007
Registry last updated
May 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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