Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure
Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure
The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).
Study Design: Multicenter, randomized, double-blind, placebo-controlled
Inclusion Criteria:
The subject must have signs of extracellular volume expansion, defined as two or more of the following: a) jugular venous distention; b) pitting edema (>1+); or c) dyspnea.
Exclusion Criteria
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Salvador, Estado de Bahia 40050-410, Brazil
Salvador, Estado de Bahia 40140-060, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Sao Jose de Rio Preto, São Paulo 15090-020, Brazil
São Paulo, São Paulo 05403-000, Brazil
Fleurimond, Quebec J1H 5N4, Canada
Plzen-Lochotin, Czechia
Bad Neustadt-Saale, Germany
Homburg/Saar, Germany
Oeyenhausen, Germany
Nordbyhagen, Norway
Saint Petersburg, Russia
Saint Petersburg, Russia