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 study has been terminated.
(additional enrolment criteria made patients' recruitment not feasible anymore)
Sponsor:
Solvay Pharmaceuticals
Collaborator:
Quintiles, Inc.
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00568009
First received: December 4, 2007
Last updated: April 18, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Congestive Heart Failure |
Drug: SLV320 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Solvay Pharmaceuticals:
Primary Outcome Measures:
- Cystatine C [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Sodium in urine [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Estimated glomerular filtration rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Clinical global impression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Body weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
Not aplicable
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | November 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: SLV320
1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Study Population
Congestive Heart Failure, Impaired Renal Function
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568009
Show 72 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568009
Show 72 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Quintiles, Inc.
Investigators
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
| Responsible Party: | Kay-Christen Meyer, Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00568009 History of Changes |
| Other Study ID Numbers: | S320.2.003 2007-000490-40 |
| Study First Received: | December 4, 2007 |
| Last Updated: | April 18, 2008 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Solvay Pharmaceuticals:
|
Congestive Heart Failure Impaired Renal Function |
Additional relevant MeSH terms:
|
Heart Failure Renal Insufficiency Heart Diseases Cardiovascular Diseases Kidney Diseases Urologic Diseases Furosemide |
Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016