NCT01146197 (GITAB) is a Phase 1/Phase 2 clinical trial of TREATMENT in Gitelman Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris.

Who is sponsoring NCT01146197?

NCT01146197 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT01146197?

Interventions in NCT01146197: TREATMENT.

What condition does NCT01146197 study?

NCT01146197 studies Gitelman Syndrome.

Is NCT01146197 still recruiting?

NCT01146197 is currently completed. Last updated 9 December 2013.

Last reviewed 2013-12-09 · How we verify

NCT01146197: GITAB

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome

Completed Phase 1/Phase 2 Last updated 9 December 2013

What this trial tests

Phase 1/Phase 2 trial testing TREATMENT in Gitelman Syndrome in 33 participants. Completed in 1 January 2013.

Timeline

1 February 2010

Primary endpoint
1 December 2012

1 January 2013

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	1 February 2010
Primary completion	1 December 2012
Estimated completion	1 January 2013
Sites	1 location across France

Drugs / interventions tested

TREATMENT — full drug profile →

Conditions studied

Gitelman Syndrome — all drugs for Gitelman Syndrome →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 60, any sex, with Gitelman Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone
Time frame: 2 months

Sponsor's own description

Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Indomethacin, amiloride, or eplerenone for treating hypokalemia in Gitelman syndrome.
Blanchard A, Vargas-Poussou R, Vallet M, Caumont-Prim A, et al · · 2015 · cited 63× · PMID 25012174 · DOI 10.1681/asn.2014030293

Verify or expand the search:

Other recruiting trials for Gitelman Syndrome

Currently open trials in the same condition.

NCT06922370 — The Osteoarticular Manifestations in Patients With Gitelman Syndrome · recruiting
NCT06065852 — National Registry of Rare Kidney Diseases · recruiting

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01146197 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
Last refreshed: 9 December 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01146197.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing