Safety and Efficacy Study to Evaluate the Effect of SLV320 on Renal Function in Patients With Worsening Heart Failure
- Conditions
- Acute Decompensated Heart Failure; Renal Dysfunction
- Interventions
- Drug: SLV320Drug: 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
Not provided
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 # 526
🇺🇸Owensboro, Kentucky, United States
S320.2.011 Site # 511
🇺🇸Houston, Texas, United States
S320.2.011 Site # 518
🇺🇸San Antonio, Texas, United States
S320.2.011 Site # 245
🇵🇱Starogard Gdanski, Poland
S320.2.011 Site # 264
🇷🇴Suceava, Romania
S320.2.011 Site # 427
🇨🇱Santiago, Chile
S320.2.011 Site # 247
🇵🇱Przeworsk, Poland
S320.2.011 Site # 234
🇵🇱Torun, Poland
S320.2.011 Site # 248
🇵🇱Torun, Poland
S320.2.011 Site # 261
🇷🇴Targoviste, Romania
S320.2.011 Site # 263
🇷🇴Bucuresti, Romania
S320.2.011 Site # 433
🇨🇱Viña del Mar, Chile
S320.2.011 Site # 232
🇵🇱Ruda Slaska, Poland
S320.2.011 Site # 262
🇷🇴Braila, Romania
S320.2.011 Site # 434
🇨🇱Viña del Mar, Chile
S320.2.011 Site # 242
🇵🇱Pulawy, Poland
S320.2.011 Site # 239
🇵🇱Radom, Poland
S320.2.011 Site # 233
🇵🇱Wroclaw, Poland
S320.2.011 Site # 105
🇩🇰Herning, Denmark
S320.2.011 Site # 292
🇷🇺Saint-Petersburg, Russian Federation
S320.2.011 Site # 298
🇷🇺Saint-Petersburg, Russian Federation
S320.2.011 Site # 302
🇷🇺Saint-Petersburg, Russian Federation
S320.2.011 Site # 300
🇷🇺St. Petersburg, Russian Federation
S320.2.011 Site # 240
🇵🇱Poznan, Poland
S320.2.011 Site # 145
🇮🇹Cremona, Italy
S320.2.011 Site # 100
🇩🇰Aarhus, Denmark
S320.2.011 Site # 103
🇩🇰Esbjerg, Denmark
S320.2.011 Site # 121
🇫🇷Paris, France
S320.2.011 Site # 146
🇮🇹Aosta, Italy
S320.2.011 Site # 125
🇫🇷Dijon, France
S320.2.011 Site # 123
🇫🇷Lille, France
S320.2.011 Site # 149
🇮🇹Milano, Italy
S320.2.011 Site # 140
🇮🇹Modena, Italy
S320.2.011 Site # 231
🇵🇱Inowroclaw, Poland
S320.2.011 Site # 143
🇮🇹Orbassano, Italy
S320.2.011 Site # 236
🇵🇱Krakow, Poland
S320.2.011 Site # 243
🇵🇱Olawa, Poland
S320.2.011 Site # 142
🇮🇹Genova, Italy
S320.2.011 Site # 299
🇷🇺Moscow, Russian Federation
S320.2.011 Site # 294
🇷🇺Kazan, Russian Federation
S320.2.011 Site # 249
🇵🇱Lodz, Poland
S320.2.011 Site # 250
🇵🇱Bialystok, Poland
S320.2.011 Site # 251
🇵🇱Plock, Poland
S320.2.011 Site # 238
🇵🇱Tychy, Poland
S320.2.011 Site # 265
🇷🇴Baia Mare, Romania
S320.2.011 Site # 306
🇷🇺Krasnodar, Russian Federation
S320.2.011 Site # 291
🇷🇺Saint-Petersburg, Russian Federation
S320.2.011 Site # 304
🇷🇺Moscow, Russian Federation
S320.2.011 Site # 267
🇷🇴Bucuresti, Romania
S320.2.011 Site # 301
🇷🇺Moscow, Russian Federation
S320.2.011 Site # 266
🇷🇴Timisoara, Romania
S320.2.011 Site # 295
🇷🇺Yaroslavl, Russian Federation
S320.2.011 Site # 335
🇺🇦Dnipropetrovsk, Ukraine
S320.2.011 Site # 338
🇺🇦Kyiv, Ukraine
S320.2.011 Site # 260
🇷🇴Bucuresti, Romania
S320.2.011 Site # 293
🇷🇺Voronezh, Russian Federation
S320.2.011 Site # 332
🇺🇦Ivano-Frankivsk, Ukraine
S320.2.011 Site # 333
🇺🇦Lutsk, Ukraine
S320.2.011 Site # 297
🇷🇺Moscow, Russian Federation
S320.2.011 Site # 334
🇺🇦Kharkiv, Ukraine
S320.2.011 Site # 330
🇺🇦Kyiv, Ukraine
S320.2.011 Site # 331
🇺🇦Lugansk, Ukraine
S320.2.011 Site # 337
🇺🇦Odessa, Ukraine
S320.2.011 Site # 305
🇷🇺Moscow, Russian Federation
S320.2.011 Site # 303
🇷🇺Moscow, Russian Federation
S320.2.011 Site # 290
🇷🇺Moscow, Russian Federation
S320.2.011 Site # 564
🇺🇸Bridgeport, Connecticut, United States
S320.2.011 Site # 551
🇺🇸Inglewood, California, United States
S320.2.011 Site # 548
🇺🇸Alameda, California, United States
S320.2.011 Site # 566
🇺🇸Banning, California, United States
S320.2.011 Site # 505
🇺🇸Hollywood, Florida, United States
S320.2.011 Site # 507
🇺🇸Jacksonville, Florida, United States
S320.2.011 Site # 513
🇺🇸Chicago, Illinois, United States
S320.2.011 Site # 561
🇺🇸Indianapolis, Indiana, United States
S320.2.011 Site # 532
🇺🇸Riverdale, Georgia, United States
S320.2.011 Site # 523
🇺🇸Dearborn, Michigan, United States
S320.2.011 Site # 504
🇺🇸Natchitoches, Louisiana, United States
S320.2.011 Site # 546
🇺🇸Biddeford, Maine, United States
S320.2.011 Site # 508
🇺🇸St. Louis, Missouri, United States
S320.2.011 Site # 528
🇺🇸Philadelphia, Pennsylvania, United States
S320.2.011 Site # 527
🇺🇸Toledo, Ohio, United States
S320.2.011 Site # 541
🇺🇸Brooklyn, New York, United States
S320.2.011 Site # 521
🇺🇸Akron, Ohio, United States
S320.2.011 Site # 537
🇺🇸New York, New York, United States
S320.2.011 Site # 510
🇺🇸Colombia, South Carolina, United States
S320.2.011 Site # 556
🇺🇸Manitowoc, Wisconsin, United States
S320.2.011 Site # 519
🇺🇸Tullahoma, Tennessee, United States
S320.2.011 Site # 601
🇨🇦Montreal, Canada
S320.2.011 Site # 102
🇩🇰Aarhus, Denmark
S320.2.011 Site # 106
🇩🇰Frederiksberg, Denmark
S320.2.011 Site # 104
🇩🇰København, Denmark
S320.2.011 Site # 126
🇫🇷Pontoise, France
S320.2.011 Site # 128
🇫🇷Toulouse, France
S320.2.011 Site # 124
🇫🇷Pessac, France
S320.2.011 Site # 185
🇩🇪Limburg, Germany
S320.2.011 Site # 182
🇩🇪Bad Nauheim, Germany
S320.2.011 Site # 180
🇩🇪Hannover, Germany
S320.2.011 Site # 186
🇩🇪Frankfurt, Germany
S320.2.011 Site # 187
🇩🇪Berlin, Germany
S320.2.011 Site # 190
🇩🇪Mannheim, Germany
S320.2.011 Site # 188
🇩🇪Weiden, Germany
S320.2.011 Site # 534
🇺🇸Detroit, Michigan, United States
S320.2.011 Site # 558
🇺🇸Detroit, Michigan, United States
S320.2.011 Site # 565
🇺🇸Milwaukee, Wisconsin, United States
S320.2.011 Site # 545
🇺🇸Nashville, Tennessee, United States