HyponatremiaPhase 3NCT00578695

THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

A Phase 3 study testing lixivaptan in people with Hyponatremia, run by CardioKine Inc. at 287 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyponatremia
What is being tested?: lixivaptan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 652 participants
Where: 287 sitesin 15 countries
Study dates: Jan 2007to Jun 2010
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.

Who cannot join

None listed.

Trial locations and contacts

287 sites in 15 countries.

Country

City, postcode or hospital

287 sites in 15 countries

United States102 sites

Research Site 1
Amarillo, Texas, 79106
Research Site 1
Atlanta, Georgia, 30322
Research Site 1
Aurora, Colorado, 80045
Research Site 1
Bakersfield, California, 93308
Research Site 1
Baltimore, Maryland, 21229
Research Site 1
Banning, California, 92220
Research Site 1
Bannockburn, Illinois, 60015
Research Site 1
Bay Pines, Florida, 33744
Research Site 1
Beaver, Pennsylvania, 15009
Research Site 1
Beloit, Wisconsin, 53511
Research Site 1
Birmingham, Alabama, 35211
Research Site 1
Birmingham, Alabama, 35294
Research Site 1
Boston, Massachusetts, 02118
Research Site 1
Burlington, Massachusetts, 01805
Research Site 1
Camp Hill, Pennsylvania, 17011
Research Site 1
Chattanooga, Tennessee, 37403
Research Site 1
Chesapeake, Virginia, 23320
Research Site 1
Chicago, Illinois, 60612
Research Site 1
Cincinnati, Ohio, 45267
Research Site 1
Columbus, Ohio, 43205
Research Site 1
Concord, New Hampshire, 03301
Research Site 1
Dallas, Texas, 75230
Research Site 1
Dallas, Texas, 75231
Research Site 1
Danville, Pennsylvania, 17822
Research Site
Detroit, Michigan, 48201
Research Site 1
Detroit, Michigan, 48202
Research Site 1
Duluth, Minnesota, 55805
Research Site 1
Fairfield, Ohio, 45014
Research Site
Fairfield, Ohio, 45014
Research Site 1
Fort Lauderdale, Florida, 33316
Research Site 1
Gainesville, Florida, 32610
Research Site 1
Galveston, Texas, 77555
Research Site 1
Germantown, Tennessee, 38138
Research Site 1
Glendale, California, 91204
Research Site
Glendale, California, 91204
Research Site 1
Hackensack, New Jersey, 07601
Research Site 1
Houston, Texas, 77030
Research Site 1
Houston, Texas, 77074
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 522442
Research Site 1
Iowa City, Iowa, 52245
Research Site 1
Jacksonville, Florida, 32209
Research Site 1
Jacksonville, Florida, 32216
Research Site 1
Jacksonville, Florida, 32224
Research Site 1
Jamaica, New York, 11418
Research Site 1
Lakeland, Florida, 33805
Research Site 1
Lincoln, Nebraska, 68506
Siant Barnabas Medical Center
Livingston, New Jersey, 07039
Research Site 1
Los Angeles, California, 90048
Research Site 1
Louisville, Kentucky, 40202
Research Site 1
Louisville, Kentucky, 40207
Research Site 1
Lubbock, Texas, 79410
Research Site 1
Madison, Wisconsin, 53792
Research Site 1
Maywood, Illinois, 60153
Research Site 1
Miami, Florida, 33136
Research Site 1
Middletown, Ohio, 45042
Research Site 1
Mission Viejo, California, 92691
Research Site 1
Mobile, Alabama, 36604
Research Site 1
Morristown, New Jersey, 07982
Research Site 1
Munster, Indiana, 46321
Research Site 1
Nashville, Tennessee, 37208
Research Site 1
New Orleans, Louisiana, 70112
Research Site
New York, New York, 10029
Research Site 1
Newark, Delaware, 19718
Research Site 1
Newark, New Jersey, 07112
Research Site 1
Normal, Illinois, 61761
Research Site 1
North Chicago, Illinois
Research Site 1
Northport, New York, 11768
Research Site 1
Oak Lawn, Illinois, 60453
Research Site 1
Oklahoma City, Oklahoma, 73112
Research Site 2
Oklahoma City, Oklahoma, 73120
Research Site 1
Orange, New Jersey, 07052
Research Site 1
Paramus, New Jersey, 07652
Research Site 1
Peoria, Illinois, 61606
Research Site 1
Peoria, Illinois, 61614
Northern Michigan Hospital
Petoskey, Michigan, 49770
Research Site 1
Petoskey, Michigan, 49770
Research Site 1
Pittsburgh, Pennsylvania, 15212
Research Site 1
Port Charlotte, Florida, 33952
Research Site 2
Richmond, Virginia, 232225
Research Site 1
Richmond, Virginia, 23249
Research Site 1
Roseville, California, 95661
Research Site 1
San Diego, California, 92103
Research Site 1
San Diego, California, 92161
Research Site1
Sayre, Pennsylvania, 18840
Research Site 1
Seattle, Washington, 98195
Research Site 1
Sellersville, Pennsylvania, 18960
Research Site 1
Slidell, Louisiana, 70458
Research Site 1
Springfield, Oregon, 97477
Research Site 1
St Louis, Missouri, 63104
Research Site 1
St Louis, Missouri, 63110
Research Site 1
Stony Brook, New York, 11794
Research Site 1
Tampa, Florida, 33606
Research Site 1
Tampa, Florida, 33613
Research Site 1
Temple, Texas, 76508
Research Site 1
The Bronx, New York, 10461
Research Site 1
Toledo, Ohio, 43614
Research Site 1
Traverse City, Michigan, 49684
Research Site 1
Tulsa, Oklahoma, 74133
Research Site 1
Tyler, Texas, 75701
Research Site 1
Valhalla, New York, 10595
Research Site 1
Washington D.C., District of Columbia, 20010
Research Site 1
Winston-Salem, North Carolina, 27157

Other trials in United States

Poland26 sites

Research Site 1
Bydgoszcz, Poland, 85-168
Research Site 1
Bydgoszcz, 85-168
Research Site
Curie 1, Nysa, 48-300
Research Site 1
Gdynia, 81-519
Research SIte
Kielce, 25-736
Research Site 1
Krakow, 31-121
Research Site 2
Krakow, 31-501
Research Site
Krakow, 31-913
Research Site
Lubartów, 21-100
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej
Ostrołęka, 07-410
Research Site 1
Ostrowiec Świętokrzyski, 27-400
Research Site
Pabianice, 95-200
Samodzielnl Szpital Wojewodzki
Piotrkow Trybunalski, 97-300
Wojewodzki Szpital Specjalistczny w Radomiu, Oddzial Kardiologil
Radom, 26-617
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Sieradz, 98-200
Research Site
Starogard Gdański, Poland
Research Site 1
Torun, 87-100
Research Site 1
Warsaw, 00-909
Research Site 1
Warsaw, 01-211
Research Site 1
Warsaw, 02-005
Research Site 1
Warsaw, 02-507
Research Site 1
Warsaw, 02-637
Wojskowy Instytut Medyczny
Warsaw, 04-141
Research Site 1
Warsaw, 04-749
Research Site 1
Wroclaw, 50-367
Research Site 1
Wroclaw, 51-124

Other trials in Poland

Russia24 sites

Research Site 1
L'va Tolstogo, Sankt-Peterburg, 197022
Research Site 1
Lenskaya, Moscow, 129327
Research SIte 1
Moscow, Russia, 109240
Research Site 1
Moscow, Russia, 111020
Research SIte 1
Moscow, Russia, 115487
Research Site 1
Moscow, Russia, 115516
Research Site 1
Moscow, Russia, 119192
Research Site 1
Moscow, Russia, 119620
Research Site 1
Moscow, Russia, 121359
Research Site 1
Moscow, Russia, 123423
Research Site 1
Moscow, Russia, 125284
Research Site 1
Moscow, Russia, 127018
Research Site 1
Moscow, Russia, 127473
Research Site
Moscow, Russia, 129110
Research Site 1
Moscow, Russia, 129301
Research Site 1
Moscow, Russia, 129336
Research Site 1
Moscow, Russia
Research Site 1
Saint Petersburg, Russia, 192242
Research Site 1
Saint Petersburg, Russia, 194156
Research Site 1
Saint Petersburg, Russia, 196247
Research Site 1
Saint Petersburg, Russia, 197110
Research Site 1
Saint Petersburg, Russia, 199106
Research Site 1
Saint Petersburg, 191187
Research Site 1
Solidamosty, Sankt-Peterburg, 193312

Other trials in Russia

Germany21 sites

Research Site 1
Bad Krozingen, 71989
Research Site 1
Bad Nauheim, 61231
Research Site 1
Bad Segeberg, 23795
Research Site 1
Berlin, 12200
Research Site 1
Berlin, 13353
Research Site 1
Bonn, 53105
Research Site 1
Coburg, 96450
Research Site 1
Dresden, 01307
Research Site 1
Göttingen, 37075
Research Site 1
Greifswald, 17475
Research Site 1
Hamburg, 20246
Research Site 1
Hanover, 30167
Research Site 1
Hanover, 30625
Research Site 1
Jena, 07747
Research Site 1
Karisbad, 76307
Research Site 1
Konstanz, 78464
Research Site 1
Leipzig, 04289
Research Site 1
Regensburg, 93053
Research Site 1
Regensburg, 94053
Research Site 1
Rostock, 18057
Research Site 1
Soest, 59494

Other trials in Germany

India20 sites

Research Site
Bangalore, Karnataka, 560 034
Research Site
Bangalore, Karnataka, 560 054
Research Site
Bangalore, Karnataka, 560052
Research Site
Bikaner, 334001
Research Site 1
Coimbatore, India
Research Site
College Road, Nashik, 422 005
Research Site 1
Madhya Pradesh, India
Research Site 1
Maharashtra, India
Research Site 1
Maharastra, India
Research Site
Mogappair, Chennai, 600037
Research Site
Mumbai, 400 007
Research Site
Naranpura, Gujarat, 380014
Sir Ganga Ram Hospital
New Delhi, New Delhi
Research Site
New Delhi, 110025
Research Site
New Delhi, 110076
Research Site
Panjagutta, Hyderabad, 500082
Research Site 1
Rajasthan, India
Research Site
Secunderabad, Andhra Pradesh, 500 003
Shree Saibaba Heart Institute and Research Centre
Shalimar, Nashik, 422 002
Sri Ramachandra Medical College of research Institute
Tamul Nadu, 600116

Other trials in India

Argentina18 sites

Research Site
Buenos Aires, Argentina, 1210
Research Site 1
Buenos Aires, Argentina, 1437
Research Site 1
Buenos Aires, Argentina, 1605
Research Site 1
Buenos Aires, Argentina, 1878
Research Site 1
Buenos Aires, Argentina, 2900
Research Site 1
Buenos Aires, Argentina, 8000
Research Site 1
Buenos Aires, Argentina, B1708KCH
Research Site
Buenos Aires, 1027
Hospital Militar Central H Gral. 601 "Cirujano Mayor Dr. Cosme Argerich"
Buenos Aires, C1426BOR
Hospital de Clinicas "Jose de San Martin"
Buenos Aires
Research Site 1
Cerrientes, Argentina
Research Site
Ciudad Autonomo de Buenos Aires, Galvan, CP FWO1431
Research Site 1
Provincia de Buenos Aires, Argentina
Research Site 1
Provincia de Misiones, Argentina, 3300
Research Site 1
Provincia de Santa Fe, Argentina
Research Site
Rosario, Santa Fe Province, CP2000
hospital Interzonal General de Agudos, "Eva Peron" (HIGA)
San Martín, Buenos Aires, 1650
Research Site 1
San Miguel de Tucumán, Argentina, 4000

Other trials in Argentina

Italy15 sites

Research Site 1
Bologna, 40138
Research Site
Brescia, Italy, 25123
Research Site 1
Cecina, 57023
Research Site 1
Cortina, 52044
Research Site 1
Genova, 16132
Research Site 1
Milan, 20132
Research Site 1
Novara, 28100
Research Site 1
Parma, 43100
Research Site 1
Pavia, Pavia, 27100
Research Site 1
Pavia, 27100
Research Site 1
Piacenza, Italy, 29100
Research Site 1
Ravenna, Italy
Research Site 1
Roma, 00161
Research Site 1
Torino, Torino, 10126
Azienda Ospedaliero-Universitaria "San Giovanni Battista di Torino" Struttura Complessa Cardiologia 1
Torino, 10126

Other trials in Italy

Canada13 sites

Research Site 1
Kitchener, Ontario, N2N 2A8
Research Site 1
Manitoba, R2H 2A6
Research Site 1
Montreal, Quebec, H2W 1T8
Research Site 1
Montreal, Quebec, H3A 1A1
Research Site 1
New Brunswick, E2K 4P8
Research Site 1
Ottawa, Ontario, K1Y 4W7
Research Site 1
Québec, G1V 4G5
Research Site 1
Québec, J6E 6J2
Research Site 1
Saint-Jérôme, Quebec, J7Z 5T3
Research Site 1
Scarborough Village, Ontario, M1P2T7
Research Site 1
Sherbrooke, Quebec, J1H 5N4
Research Site 1
Toronto, Ontario, M5G 2N2
Research Site 1
Vancouver, V6Z 1Y6

Other trials in Canada

Czechia12 sites

Research Site 1
Havlíčkův Brod, 580 22
Research Site 1
Kladno, 272 59
Research Site 1
Kroměříž, 767 55
Research Site 1
Liberec, 460-63
Research Site 1
Městec Králové, 289 03
Research Site 1
Ostrava, 72880
Research Site 1
Prague, 128 08
Research Site 1
Prague, 150 30
Research Site 1
Prague, 180 81
Research Site 1
Prague
Research Site 1
Příbram, 261 26
Research Site 1
Znojmo, 669 02

Other trials in Czechia

Israel10 sites

Research Site 1
Beersheba, Israel, 84101
Research Site
Haifa, Israel, 31048
Research Site 1
Haifa, 31048
Research Site 1
Holon, Israel, 58100
Research Site
Jerusalem, Israel, 91120
Research Site 1
Jerusalem, Israel, 91240
Research Site 1
Jerusalem, 91004
Research Site 1
Petah Tkva, Israel
Research Site 1
Safed, Safed, 13100
Research Site 1
Tel Aviv, Tel Aviv, 64239

Other trials in Israel

Chile9 sites

Research Site 1
Antofagasta, Chile, 1945
Research Site 1
Concepción, Chile
Research Site 1
Orosno, Chile
Hospital de Puerto Montt
Port Montt
Research Site 1
Santiago, Chile, 3204
Research Site 1
Santiago, Chile
Research Site
Santiago, 0155
Research Site
Temuco, Chile, 115
Research Site 1
Viña del Mar, Chile, 1532

Other trials in Chile

Spain8 sites

Research Site 1
Barcelona, 08003
Research Site 1
Barcelona, 08036
Research Site 1
Córdoba, 14004
Research Site 1
Madrid, 28007
Hospital Univeritario Virgen de la Victoria Servicio de Cardiologia
Málaga, 29010
Research Site 1
Málaga, 29010
Research Site 1
Santiago de Compostela, 15706
Research Site 1
Vigo, 36200

Other trials in Spain

Romania5 sites

Research Site
Brasov, Romania, 500152
Research Site 1
Bucharest, Romania, 030572
Research Site 1
Bucharest, 014461
Research Site 1
Tg Mures, Romania, 540136
Research Site 1
Timișoara, 300310

Other trials in Romania

Slovakia3 sites

Research Site 1
Bratislava, 826 06
Research Site 1
Nitra, 949 01
Interna klinika, Fakultna nemocnica Trencin
Trenčín, 91171

Other trials in Slovakia

Switzerland1 site

Research Site
Geneva, 1217

Other trials in Switzerland

About this study

The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.

Conditions: Hyponatremia
Being tested: lixivaptan, Placebo
Keywords: Hyponatremia, Serum Sodium, Fluid Overload, Heart Failure, Acute Heart Failure, Vasopressin Antagonist
Medical subject headings: Hyponatremia, Edema, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lixivaptanDrug
Oral Capsule
PlaceboDrug
Oral Capsule

Study groups in NCT00578695
Study group	Role	What they receive
Active	Experimental	Lixivaptan Receives: Drug: lixivaptan
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated.
Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Jun 2010

First posted21 Dec 2007 (estimated)
Study startJan 2007
Primary completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HyponatremiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 652 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00578695
Sponsor's protocol ID: CK-LX3401
Status last verified: Nov 2010
First submitted: 19 Dec 2007
Last updated: 28 Jun 2011
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome

All Hyponatremia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
ClinicalTrials.gov ID: NCT00578695
Acronym / sponsor ID: CK-LX3401
Conditions: Hyponatremia
Keywords: Hyponatremia, Serum Sodium, Fluid Overload, Heart Failure, Acute Heart Failure, Vasopressin Antagonist
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 652 participants (actual)
Lead sponsor: CardioKine Inc.Industry (pharma, biotech, devices)
Collaborators: Cardiokine Biopharma, LLC, Biogen
Study start: Jan 2007
Primary completion: Jun 2010 (actual)
First posted: 21 Dec 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active	Experimental	Drug: lixivaptanLixivaptan
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lixivaptanOral Capsule	Drug	Active
PlaceboOral Capsule	Drug	Placebo

Primary outcome

To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated.
Time frame: 60 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.

Related trials for Hyponatremia

RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

287 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lixivaptan in people with Hyponatremia, run by CardioKine Inc. at 287 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 287 sites in United States, Poland, Russia, Germany, India and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated. (time frame: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00578695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.