NCT00568009

Terminated

Study to Evaluate the Effect of SLV320 in Addition to Chroni...

Solvay Pharmaceuticals Source

NCT00568009|TerminatedDMC

Study Stopped

additional enrolment criteria made patients' recruitment not feasible anymore

Study to Evaluate the Effect of SLV320 in Addition to Chronic Furosemide Treatment on Renal Function in Subjects With Congestive Heart Failure and Impaired Renal Function

Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Sequential Cohort Study to Evaluate the Effect of SLV320 in Addition to Chronic Furosemide Treatment on Renal Function in Subjects With Congestive Heart Failure and Impaired Renal Function

Solvay Pharmaceuticals

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

S320.2.003

Secondary identifiers

2007-000490-40

Study Type

observational

Estimated enrollment

300

Locations

9 countries

Sites

66

Timeline

Study Start

October 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2008

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

November 2008

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center, sequential cohort study in subjects with congestive heart failure (CHF) and impaired renal function who are on stable furosemide treatment (³ 40 mg daily). A total of 50 subjects will be randomized to each increasing dose level of SLV320 or placebo in a sequential fashion.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Estimated enrollment: 300 participants
Study completion date: November 2008
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 9 countries · 66 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 4, 2007
Actual (reported)
First Posted
December 5, 2007
Actual (reported)
Primary Completion
November 2008
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2008
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: April 22, 2008
Status Verified: April 2008
Last Update Submitted: April 18, 2008

Conditions

Congestive Heart Failure

Keywords

Congestive Heart FailureImpaired Renal Function

Outcome Measures

Primary Outcomes (1)

Cystatine C
3 months

Secondary Outcomes (4)

Sodium in urine
3 months
Estimated glomerular filtration rate
3 months
Clinical global impression
3 months
Body weight
3 months

Interventions

SLV320Drug

1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Study Population

Congestive Heart Failure, Impaired Renal Function

You may qualify if:

Male and female subjects aged 18 to85 years who gave written informed consent.

Sponsors & Collaborators

Solvay Pharmaceuticals
Industrylead
Quintiles, Inc.
Industrycollaborator

Study Sites (72)

Site 96

Whittier, California, United States

Site 95

Largo, Florida, United States

Site 90

Miami, Florida, United States

Site 88

Atlanta, Georgia, United States

Site 92

Covington, Georgia, United States

Site 106

Melrose Park, Illinois, United States

Site 87

Hagerstown, Maryland, United States

Biospecimen

Retention: NONE RETAINED

Not aplicable

MeSH Terms

Conditions

Heart FailureRenal Insufficiency

Interventions

SLV320 compound

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

Global Clinical Director Solvay
Solvay Pharmaceuticals
STUDY DIRECTOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

October 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2008

Estimated (date passed)

NCT00480961

Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

Phase 2Unknown

NCT00559650

Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667

Phase 2Terminated

NCT00369044

Prednisone for Decompensated Congestive Heart Failure

Phase 2/3Suspended

NCT00383630

Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure

Phase 2Terminated

NCT00283361

ZP120 Add-on to Furosemide in Treatment of Acute or Sub-Acute Decompensated Heart Failure

Phase 2Terminated

NCT00782782

Vascular Sensitivity to Adrenergic Agonists in Patients With CHF and in Healthy Subjects

Unknown

Subjects must have a history of chronic, symptomatic, New York Heart Association (NYHA) Class II-III CHF and impaired renal function (baseline eGFR of 20 to 75 mL/min/1.73m2).

Congestive heart failure should have been diagnosed at least 3 months before Visit 1 (Day 1) and the subjects should be on chronic treatment with furosemide (40 mg daily) for at least 3 weeks before Visit 1 (Day 1).

Subjects must be on stable doses of their individually optimized medication regimen for at least 4 weeks before Visit 1 (Day 1).

You may not qualify if:

Females of childbearing potential not using specified contraception, subjects with malignant tumors with a short life expectancy, subjects with known severe reactions to drugs and subjects with bilateral renal artery stenosis will be excluded from the study.

Contact the study team to confirm eligibility.

Site 94

Springfield Gardens, New York, United States

Site 89

Dallas, Texas, United States

Site 97

San Antonio, Texas, United States

Site 11

Bahía Blanca, Argentina

Site 2

Bahía Blanca, Argentina

Site 101

Capital Federal, Argentina

Site 6

Coronel Suárez, Argentina

Site 1

Corrientes, Argentina

Site 5

La Plata, Argentina

Site 104

Mar del Plata, Argentina

Site 102

Salta, Argentina

Site 105

San Luis, Argentina

Site 4

San Martin, Argentina

Site 8

Santa Fe, Argentina

Site 14

Antwerp, Belgium

Site 15

Ghent, Belgium

Site 12

Huy, Belgium

Site 22

Brno, Czechia

Site 16

Jindřichův Hradec, Czechia

Site 19

Kroměříž, Czechia

Site 20

Prague, Czechia

Site 21

Prague, Czechia

Site 17

Semily, Czechia

Site 18

Slaný, Czechia

Site 23

Teplice, Czechia

Site 24

Bad Nauheim, Germany

Site 28

Berlin, Germany

Site 26

Dortmund, Germany

Site 50

Bydgoszcz, Poland

Site 47

Lublin, Poland

Site 49

Płock, Poland

Site 57

Skierniewice, Poland

Site 54

Torun, Poland

Site 48

Warsaw, Poland

Site 52

Warsaw, Poland

Site 53

Warsaw, Poland

Site 56

Warsaw, Poland

Site 55

Wroclaw, Poland

Site 51

Zielona Góra, Poland

Site 58

Moscow, Russia

Site 61

Moscow, Russia

Site 62

Moscow, Russia

Site 63

Moscow, Russia

Site 64

Moscow, Russia

Site 60

Saint Petersburg, Russia

Site 59

Samara, Russia

Site 65

Belgrade, Serbia and Montenegro

Site 66

Belgrade, Serbia and Montenegro

Site 69

Belgrade, Serbia and Montenegro

Site 68

Niska Banja, Serbia and Montenegro

Site 67

Sremska Kamenica, Serbia and Montenegro

Site 70

Zemun, Serbia and Montenegro

Site 72

Belville, South Africa

Site 75

Belville, South Africa

Site 76

Bloemfontein, South Africa

Site 98

Durban, South Africa

Site 73

Kempton Park, South Africa

Site 71

Somerset West, South Africa

Site 74

Worcester, South Africa

Site 78

Barcelona, Spain

Site 83

Barcelona, Spain

Site 79

Madrid, Spain

Site 77

Málaga, Spain

Site 82

Santander, Spain

Site 80

Valencia, Spain

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

November 2008

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

April 22, 2008

Record last verified: 2008-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00568009
Data provider: ClinicalTrials.gov
Source updated: 2008-04-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:21 UTC

Locations

AR(11)BE(3)CZ(8)DE(3)ES(6)PL(11)RU(7)US(10)ZA(7)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (72)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations