A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia

NCT01451411 | Terminated Phase 3 Results DMC

• 1 other identifier: 087-CL-096
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 3

Brief Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in blood.

Conditions

Hyponatremia

Keywords

Serum Sodium; Euvolemia; Hypervolemia; Vaprisol®; Conivaptan; YM087

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium

  baseline and 48 hours

Secondary Outcomes (8)

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

  48 hours

• Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium

  baseline and 48 hours

• Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L)

  baseline and 48 hours

• Change From Baseline in Effective Water Clearance (EWC) Every 12 Hours

  Baseline, Hours 12, 24, 36 and 48

• Change From Baseline in Free Water Clearance (FWC)

  Baseline and 48 hours

Study Arms (2)

Conivaptan hydrochloride

EXPERIMENTAL

Drug: Conivaptan hydrochloride

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Conivaptan hydrochloride DRUG

Intravenous

Also known as: Vaprisol®, YM087

Conivaptan hydrochloride

Placebo DRUG

Intravenous

Placebo

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject is euvolemic or hypervolemic hyponatremia upon clinical presentation
• Female subject of childbearing potential must have a negative serum pregnancy test and must be premenarchal, surgically sterile or must practice a method of birth control

You may not qualify if:

• Female subject is pregnant or lactating
• Subject has a body mass index (BMI) \< the 3rd percentile or \> the 97th percentile for their age and stature according to the World Health Organization; Body mass index-for-age percentiles charts for boys and girls ages 2 to 20
• Subject has clinical evidence of volume depletion, dehydration or hypovolemia
• Subject with hypovolemic hyponatremia or transient causes of hyponatremia that are likely to resolve during the time of study participation
• Subjects with a cause of hyponatremia that is most appropriately corrected by alternative therapies
• Subject is expected to receive emergent treatment for hyponatremia during the treatment period of the study
• Subject has clinical evidence of hypotension
• Subject has uncontrolled hypertension \> the 99th percentile for their age
• Subject has uncontrolled bradyarrhythmias or tachyarrhythmias requiring emergent pacemaker placement or treatment
• Subject has untreated severe hypothyroidism, hyperthyroidism or adrenal insufficiency
• Subject has known urinary outflow obstruction, unless subject is, or can be catheterized during the study
• Subject has estimated creatinine clearance \< 30 mL/min during the seven days prior to study drug administration
• Subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations \> 3 times the upper limit of normal reference range during the seven days prior to study drug administration
• Subject has serum albumin ≤ 1.5 g/dL during the seven days prior to study drug administration
• Subject has white blood cell count (WBC) \< 3000/micro-liter documented any time during seven days prior to study drug administration or anticipated drop in WBC to \< 3000/micro-liter during the period of the study due to chemotherapy

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (3)

Children's Hospital of New York - Presbyterian

New York, New York, 10032, United States

Location

Fundación Cardioinfantil - Instituto Cardiológico

Bogotá, Colombia

Location

Fundación Valle del Lili

Cali, Valle, Colombia

Location

MeSH Terms

Conditions

Hyponatremia; Edema

Interventions

conivaptan

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Amy Rock, PhD
• Organization: Cumberland Pharmaceuticals Inc.

arock@cumberlandpharma.com

615-255-0068

Study Officials

• Art Wheeler, MD

  Cumberland Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 13, 2011
• Study Start: February 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 1, 2016
• Results First Posted: March 1, 2016

Record last verified: 2016-02

Locations

US (1); CO (2)