Safety and Efficacy Study to Evaluate the Effect of SLV320 on Renal Function in Patients With Worsening Heart Failure

Phase 2

Terminated

• Conditions: Acute Decompensated Heart Failure; Renal Dysfunction
• Interventions: Drug: SLV320; Drug: Placebo

• Registration Number: NCT00744341
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

Detailed Description

The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

Study Timeline

• Study First Submitted: 2008-08-28
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Study Start: 2009-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-16
• Last Update Posted: 2010-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SLV320	-
2	SLV320	-
3	SLV320	-
4	SLV320	-
5	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in serum creatinine from baseline to Day 14	Day 14

Secondary Outcome Measures

Name	Time	Method
To compare four SLV320 doses to placebo on the change in the following variables: Dyspnea (Likert Scale and PDA scale), eGFR (MDRD Formula), Subject Global Clinical Assessment Score, Urine Osmolality, Serum Osmolality	Up to Day 3 (Dyspnea); Up to Day 4 (Urine Osmolality); Up to Day 60 (eGFR, Subject Global Clinical Assessment Score, Serum Osmolality)
To compare the effect of four I.V. doses of SLV320 with placebo using the trichotomous endpoint of treatment success, treatment failure, or no change	Up to Day 14
To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use	Up to Day 3
To compare the effect of four I.V. doses of SLV320 with placebo using a composite endpoint of all-cause mortality, cardiovascular hospitalization or hospitalization for worsening renal function, in time to event and frequency	Up to Day 180
To determine the pharmacokinetic profile of I.V. SLV320	Up to Day 3

Trial Locations

Locations (105)

S320.2.011 Site # 548; 🇺🇸 Alameda, California, United States

S320.2.011 Site # 566; 🇺🇸 Banning, California, United States

S320.2.011 Site # 551; 🇺🇸 Inglewood, California, United States

S320.2.011 Site # 564; 🇺🇸 Bridgeport, Connecticut, United States

S320.2.011 Site # 505; 🇺🇸 Hollywood, Florida, United States

S320.2.011 Site # 507; 🇺🇸 Jacksonville, Florida, United States

S320.2.011 Site # 532; 🇺🇸 Riverdale, Georgia, United States

S320.2.011 Site # 513; 🇺🇸 Chicago, Illinois, United States

S320.2.011 Site # 561; 🇺🇸 Indianapolis, Indiana, United States

S320.2.011 Site # 526; 🇺🇸 Owensboro, Kentucky, United States

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