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

April 18, 2008 updated by: Solvay Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina
        • Site 11
      • Bahia Blanca, Argentina
        • Site 2
      • Capital Federal, Argentina
        • Site 101
      • Coronel Suarez, Argentina
        • Site 6
      • Corrientes, Argentina
        • Site 1
      • La Plata, Argentina
        • Site 5
      • Mar del Plata, Argentina
        • Site 104
      • Salta, Argentina
        • Site 102
      • San Luis, Argentina
        • Site 105
      • San Martin, Argentina
        • Site 4
      • Santa Fe, Argentina
        • Site 8
  • Belgium
      • Antwerpen, Belgium
        • Site 14
      • Gent, Belgium
        • Site 15
      • Huy, Belgium
        • Site 12
  • Czech Republic
      • Brno, Czech Republic
        • Site 22
      • Jindrichuv Hradec, Czech Republic
        • Site 16
      • Kromeriz, Czech Republic
        • Site 19
      • Praha, Czech Republic
        • Site 20
      • Praha, Czech Republic
        • Site 21
      • Semily, Czech Republic
        • Site 17
      • Slany, Czech Republic
        • Site 18
      • Teplice, Czech Republic
        • Site 23
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro
        • Site 65
      • Belgrade, Former Serbia and Montenegro
        • Site 66
      • Belgrade, Former Serbia and Montenegro
        • Site 69
      • Niska Banja, Former Serbia and Montenegro
        • Site 68
      • Sremska Kamenica, Former Serbia and Montenegro
        • Site 67
      • Zemun, Former Serbia and Montenegro
        • Site 70
  • Germany
      • Bad Nauheim, Germany
        • Site 24
      • Berlin, Germany
        • Site 28
      • Dortmund, Germany
        • Site 26
  • Poland
      • Bydgoszcz, Poland
        • Site 50
      • Lublin, Poland
        • Site 47
      • Plock, Poland
        • Site 49
      • Skierniewice, Poland
        • Site 57
      • Torun, Poland
        • Site 54
      • Warszawa, Poland
        • Site 48
      • Warszawa, Poland
        • Site 52
      • Warszawa, Poland
        • Site 53
      • Warszawa, Poland
        • Site 56
      • Wroclaw, Poland
        • Site 55
      • Zielona Gora, Poland
        • Site 51
  • Russian Federation
      • Moscow, Russian Federation
        • Site 58
      • Moscow, Russian Federation
        • Site 61
      • Moscow, Russian Federation
        • Site 62
      • Moscow, Russian Federation
        • Site 63
      • Moscow, Russian Federation
        • Site 64
      • Samara, Russian Federation
        • Site 59
      • saint-Petersburg, Russian Federation
        • Site 60
  • South Africa
      • Belville, South Africa
        • Site 72
      • Belville, South Africa
        • Site 75
      • Bloemfontein, South Africa
        • Site 76
      • Durban, South Africa
        • Site 98
      • Kempton Park, South Africa
        • Site 73
      • Somerset West, South Africa
        • Site 71
      • Worcester, South Africa
        • Site 74
  • Spain
      • Barcelona, Spain
        • Site 78
      • Barcelona, Spain
        • Site 83
      • Madrid, Spain
        • Site 79
      • Malaga, Spain
        • Site 77
      • Santander, Spain
        • Site 82
      • Valencia, Spain
        • Site 80
  • United States
    • California
      • Whittier, California, United States
        • Site 96
    • Florida
      • Largo, Florida, United States
        • Site 95
      • Miami, Florida, United States
        • Site 90
    • Georgia
      • Atlanta, Georgia, United States
        • Site 88
      • Covington, Georgia, United States
        • Site 92
    • Illinois
      • Melrose Park, Illinois, United States
        • Site 106
    • Maryland
      • Hagerstown, Maryland, United States
        • Site 87
    • New York
      • Springfield Gardens, New York, United States
        • Site 94
    • Texas
      • Dallas, Texas, United States
        • Site 89
      • San Antonio, Texas, United States
        • Site 97

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Population

Congestive Heart Failure, Impaired Renal Function

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Any history of a convulsive disorder or pre-convulsive state and any risk for a convulsive disorder or pre-convulsive state (for example any past brain trauma, abuse of alcohol) will lead to an exclusion from the study.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cystatine C
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sodium in urine
Time Frame: 3 months
3 months
Estimated glomerular filtration rate
Time Frame: 3 months
3 months
Clinical global impression
Time Frame: 3 months
3 months
Body weight
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Collaborators

Quintiles, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Anticipated)

November 1, 2008

Study Completion (Anticipated)

November 1, 2008

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 18, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S320.2.003
  • 2007-000490-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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