CompletedPhase 3

Study of Ascending Levels of Tolvaptan in Hyponatremia

Germany243 participantsStarted 2003-11-01

Plain-language summary

The purpose of this study was to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal and to characterize and quantify the potential clinical benefits of this treatment.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Hyponatremia in euvolemic or hypervolemic states, defined as serum sodium \< 135 mEq/L prior to randomization.
. Able to give Informed Consent.

Exclusion criteria

. Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
. Hyponatremia in hypovolemic states.
. Acute and transient hyponatremia associated with head trauma or post-operative state.
. Hyponatremia due to uncontrolled hypothyroidism or uncontrolled adrenal insufficiency.
. Cardiac surgery within 30 days of potential study enrollment, excluding percutaneous coronary interventions.
. History of a myocardial infarction within 30 days of potential study enrollment.
. History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
. Severe angina including angina at rest or at slight exertion and/or unstable angina.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00201994

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-07-01

View on ClinicalTrials.gov More Hyponatremia trials