Evaluation of Safety and Effects of SLx-4090 After Dosing for 14 Days in Subjects With High Triglycerides

NCT ID: NCT00562575

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-02-29

Brief Summary

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The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides.

Detailed Description

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1. Serum triglycerides
2. Serum lipids and lipoproteins
3. Safety and tolerability

Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

SLx-4090

Group Type EXPERIMENTAL

SLx-4090

Intervention Type DRUG

2

Matching Placebo Dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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SLx-4090

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects with high triglyceride levels
* Male or female subjects between age 18 and 65 years, inclusive

Exclusion Criteria

* History of drug abuse
* Any prescribed or over the counter medication taken within 2 weeks prior to administration of study drug or within 6 times the elimination half-life
* Blood donation of more than 500ml blood in the previous 3 months
* Any confirmed significant allergic reaction against any drug or multiple allergies
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Response Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grit Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

FOCUS clinical Drug Development GmbH

Locations

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FOCUS Clinical Drug Development GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SLx-4090-07-03

Identifier Type: -

Identifier Source: org_study_id

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