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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cystatine C
Time Frame: 3 months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Solvay Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2008

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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