Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01214421Tipo: INTERVENTIONALInicio: 26 de may de 2010Fin estimado: 29 de feb de 2016

Traducción no disponible, mostrando original

Resumen

To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

\- Participants who had successfully completed a Phase 1, 2, or 3 tolvaptan ADPKD or renal impairment study, with a confirmed diagnosis of ADPKD from prior studies \[either 156-04-251 (NCT00428948) or 156-04-250 (NCT00413777), 156-06-260, 156-09-284 (NCT01336972), 156-09-285 (NCT01210560), and 156-09-290 (NCT01451827)\].

Criterios de exclusión

Participants (men or women) would not adhere to the reproductive precautions as outlined in the Informed Consent Form.
Participants unable to provide written informed consent.
Participants (women only) with a positive urine pregnancy test.
Participants who were pregnant or breast-feeding.
Participants unable to take oral medications.
Participants who had allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate, or mirtazapine).
Participants with disorders in thirst recognition or an inability to access fluids.
Participants with critical electrolyte imbalances, as determined by the investigator
Participants with or at risk of significant hypovolemia, as determined by investigator.
Participants with significant anemia, as determined by investigator.
Participants with a history of substance abuse (within the last 3 years).
Participants who were taking other experimental (that is, non-marketed) therapies or were participating in another clinical drug or device study; participating in the off-drug follow-up period of another ADPKD trial with tolvaptan was permitted.
Participants unable to complete magnetic resonance imaging (MRI) assessments (for example, participants with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia).
Participants who had taken a vasopressin antagonist (outside of previous participation in a tolvaptan study).
Participants unable to comply with anti-hypertensive or other important medical therapy.
Participants with advanced diabetes.
Participants who were taking medications or had an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting polycystic kidney disease \[PKD\] cysts).

Intervenciones

drug

Tolvaptan

Tablets of 15 or 30 mg

Ubicaciones

Otsuka Investigational Site

C.a.b.a., Buenos Aires, Argentina

Otsuka Investigational Site

Pilar, Buenos Aires, Argentina

Otsuka Investigational Site

Buenos Aires, Argentina

Otsuka Investigational Site

Córdoba, Argentina

Otsuka Investigational Site

Córdoba, Argentina

Patrocinadores

PrincipalOtsuka Pharmaceutical Development & Commercialization, Inc.

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