NCT01507727

Brief Summary

This drug has been developed to treat Hyponatremia. The primary purpose of this study is to verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15, 30, and 60 mg or placebo in patients with Non-hypovolemic Non-acute Hyponatremia secondary to Congestive Heart Failure (CHF), hepatic cirrhosis or Syndrome of Inappropriate Antidiuretic Hormone (SIADH), despite receiving standard therapy. This study is being conducted in China.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

January 5, 2012

Last Update Submit

January 8, 2012

Conditions

Non-hypovolemic Non-acute Hyponatremia

Keywords

hyponatremiaNon-hypovolemic and Non-acute hyponatremiaTolvaptan

Outcome Measures

Primary Outcomes (1)

  • The change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period

    4 and 7 days

Secondary Outcomes (12)

  • Percentage of patients with normalized serum sodium at Day 4

    4 day

  • Percentage of patients with normalized serum sodium at Day 7

    7 day

  • Time to first normalization in serum sodium

    up to 7 days

  • Change from baseline in serum sodium at Day 4

    4 day

  • Change from baseline in serum sodium at Day 7

    7 day

  • +7 more secondary outcomes

Study Arms (2)

Drug: Tolvaptan

EXPERIMENTAL
Drug: Tolvaptan

Drug: Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TolvaptanDRUG

Tablet;15mg/tab; 30mg/tab; 15/30/60mg/day for 7 days Plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.

Drug: Tolvaptan
PlaceboDRUG

placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.

Drug: Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CHF who exhibit edema, jugular venous distention, hepatomegaly, or pulmonary congestion.
  • Non-hypovolemic and Non-acute hyponatremia with a serum sodium \< 135mEq/L before randomization.
  • Patients who have taken furosemide at 40 mg/d or more (oral dosing) without alteration of dosage for the 3 days of the observation period.
  • Patients whose body weight has been stable (±1.0 kg) for 2 days prior to commencement of study drug administration.
  • Age:18～80 (when informed consent is obtained)，male or female.
  • In-patient subjects.
  • Informed consent.
  • Patients with hepatic edema.
  • Non-hypovolemic and non acute hyponatremia with a serum sodium \< 135mEq/L before randomization.
  • Age:18～65 (when informed consent is obtained)，male or female.
  • In-patient subjects.
  • Informed consent.
  • Patients with SIADH arising from a variety of etiologies.
  • Non-hypovolemic and non acute hyponatremia with a serum sodium \< 135mEq/L before randomization.
  • Age:18～80 (when informed consent is obtained)，male or female.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science

Beijing, China

RECRUITING

Endocrinology, Beijing Friendship Hospital

Beijing, China

RECRUITING

Hepatology, No. 302 Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hyponatremia

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Fusheng Wang, PhD

CONTACT

fswang@public.bta.net.cn

Lin Zhu

CONTACT

051885475957acetone_zhulin@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 2
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

January 5, 2012

First Posted

January 11, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

CN(3)