## Protocol Section
### Identification Module
**NCT ID:** NCT00810979

**Brief Title:** Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia

**Official Title:** A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Different Doses of SLx-4090 in Combination With a Statin vs. Statin Mono-therapy in Patients With Hyperlipidemia

#### Organization Study ID Info
**ID:** SLx-4090-08-06
#### Organization
**Class:** INDUSTRY
**Full Name:** Response Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2009-09

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2014-12-31

**Type:** ESTIMATED

**Disp First Submit Date:** 2014-12-09
**Disp First Submit QC Date:** 2014-12-10

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-09

**Type:** ACTUAL

#### Start Date
**Date:** 2009-01

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2008-12-18
**Type:** ESTIMATED
**Study First Submit Date:** 2008-12-17
**Study First Submit QC Date:** 2008-12-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Response Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.

**Detailed Description:** 1. LDL-C after 12 weeks of treatment
2. Safety and tolerability
3. Plasma levels of SLx-4090

### Conditions Module

**Conditions:**

- Hyperlipidemia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 133

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.

**Intervention Names:**

- Drug: SLx-4090

- Drug: Statin

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.

**Intervention Names:**

- Drug: SLx-4090

- Drug: Statin

**Label:** 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.

**Intervention Names:**

- Other: Placebo

- Drug: Statin

**Label:** 3

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** tablet

**Name:** SLx-4090

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** tablet

**Name:** SLx-4090

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- 3

**Description:** matching tablet

**Name:** Placebo

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- 1

- 2

- 3

**Description:** Subjects were dosed with the statin prescribed specifically by their prescribing physician.

**Name:** Statin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Reduction in LDL-C

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Measure:** Adverse events

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* LDL-C \> or = 100 mg/dL
* On stable statin therapy for at least 6 weeks

Exclusion Criteria:

* Coronary heart disease or risk factors for CHD

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**State:** Alabama

**Zip:** 35209

**Location 2:**

**City:** Tempe

**Country:** United States

**State:** Arizona

**Zip:** 85282

**Location 3:**

**City:** Tucson

**Country:** United States

**State:** Arizona

**Zip:** 85710

**Location 4:**

**City:** Jacksonville

**Country:** United States

**State:** Florida

**Zip:** 32205

**Location 5:**

**City:** Atlanta

**Country:** United States

**State:** Georgia

**Zip:** 30342

**Location 6:**

**City:** Addison

**Country:** United States

**State:** Illinois

**Zip:** 60101

**Location 7:**

**City:** Chicago

**Country:** United States

**State:** Illinois

**Zip:** 60611

**Location 8:**

**City:** Chicago

**Country:** United States

**State:** Illinois

**Zip:** 60654

**Location 9:**

**City:** Indianapolis

**Country:** United States

**State:** Indiana

**Zip:** 46260

**Location 10:**

**City:** Louisville

**Country:** United States

**State:** Kentucky

**Zip:** 40213

**Location 11:**

**City:** Edina

**Country:** United States

**State:** Minnesota

**Zip:** 55435

**Location 12:**

**City:** Saint Louis

**Country:** United States

**State:** Missouri

**Zip:** 63141

**Location 13:**

**City:** Rochester

**Country:** United States

**State:** New York

**Zip:** 14609

**Location 14:**

**City:** Raleigh

**Country:** United States

**State:** North Carolina

**Zip:** 27609

**Location 15:**

**City:** Cincinnati

**Country:** United States

**State:** Ohio

**Zip:** 45212

**Location 16:**

**City:** Cincinnati

**Country:** United States

**State:** Ohio

**Zip:** 45219

**Location 17:**

**City:** Cleveland

**Country:** United States

**State:** Ohio

**Zip:** 44122

**Location 18:**

**City:** Mount Pleasant

**Country:** United States

**State:** South Carolina

**Zip:** 29464

**Location 19:**

**City:** Richmond

**Country:** United States

**State:** Virginia

**Zip:** 23294

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050171

- Term: Dyslipidemias

- ID: D000052439

- Term: Lipid Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10000

- Name: Hyperlipidemias

- Relevance: HIGH

- As Found: Hyperlipidemia

- ID: M10002

- Name: Hyperlipoproteinemias

- Relevance: HIGH

- As Found: Hyperlipidemia

- ID: M26181

- Name: Dyslipidemias

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27029

- Name: Lipid Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006949

- Term: Hyperlipidemias

- ID: D000006951

- Term: Hyperlipoproteinemias

### Intervention Browse Module - Browse Branches

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21155

- Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
