## Protocol Section
### Identification Module
**NCT ID:** NCT01446679

**Acronym:** ALWAYS

**Brief Title:** Special Drug Use-Results Survey of Lipitor Tablets

**Official Title:** Special Drug Use-Results Survey of Lipitor Tablets

#### Organization Study ID Info
**ID:** LIP003
#### Organization
**Class:** INDUSTRY
**Full Name:** Astellas Pharma Inc
### Status Module
#### Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-02-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-02-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Start Date
**Date:** 2010-09

**Status Verified Date:** 2013-02

#### Study First Post Date
**Date:** 2011-10-05
**Type:** ESTIMATED
**Study First Submit Date:** 2011-09-22
**Study First Submit QC Date:** 2011-10-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Astellas Pharma Inc

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve the category-specific targeted lipid levels.

**Detailed Description:** To confirm the low-density lipoprotein cholesterol (LDL-C)-lowering effect of 24 weeks of treatment with Lipitor®(Generic Name : atorvastatin calcium) Tablets and determine the rate of achievement of the category-specific target LDL-C level in patients with hypercholesterolemia; and to confirm the usefulness (efficacy and safety) of atorvastatin in patients who have not responded sufficiently to other statin therapies

### Conditions Module

**Conditions:**

- Hypercholesterolemia

**Keywords:**

- Lipitor

- HMG-CoA reductase inhibitor

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 24050

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Who receive atrovastatin

**Intervention Names:**

- Drug: atrovastatin

**Label:** atrovastatin group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- atrovastatin group

**Description:** oral

**Name:** atrovastatin

**Other Names:**

- Lipitor

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Changes in plasma LDL-C concentration

**Time Frame:** 0, 4, 12 and 24 week

**Measure:** Change in rate of achievement of the category-specific target LDL-C level

**Time Frame:** 0, 4, 12 and 24 week

#### Secondary Outcomes

**Measure:** Change in plasma lipid values (LDL cholesterol, HDL cholesterol, triglycerides, total cholesterol, and malondialdehyde-modified LDL [MDL-LDL])

**Time Frame:** 0, 4, 12 and 24 week

**Measure:** Changes in renal function test values (urinary albumin, urinary creatinine, urinary protein, and serum creatinine)

**Time Frame:** 0, 4, 12 and 24 week

### Eligibility Module

**Eligibility Criteria:** Patients with hypercholesterolemia who have not achieved the category-specific target lipid level

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients with hypercholesterolemia who have not achieved the category-specific target lipid level in other statin therapies

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chubu

**Country:** Japan

**Location 2:**

**City:** Chugoku

**Country:** Japan

**Location 3:**

**City:** Hokkaido

**Country:** Japan

**Location 4:**

**City:** Kansai

**Country:** Japan

**Location 5:**

**City:** Kantou

**Country:** Japan

**Location 6:**

**City:** Kyushu

**Country:** Japan

**Location 7:**

**City:** Shikoku

**Country:** Japan

**Location 8:**

**City:** Touhoku

**Country:** Japan

#### Overall Officials

**Official 1:**

**Affiliation:** Astellas Pharma Inc

**Name:** Use Central Contract

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006949

- Term: Hyperlipidemias

- 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: M9988

- Name: Hypercholesterolemia

- Relevance: HIGH

- As Found: Hypercholesterolemia

- ID: M10000

- Name: Hyperlipidemias

- Relevance: LOW

- As Found: Unknown

- ID: M10002

- Name: Hyperlipoproteinemias

- Relevance: LOW

- As Found: Unknown

- 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: D000006937

- Term: Hypercholesterolemia

### Intervention Browse Module - Ancestors

- ID: D000000924

- Term: Anticholesteremic Agents

- ID: D000000960

- Term: Hypolipidemic Agents

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000057847

- Term: Lipid Regulating Agents

- ID: D000019161

- Term: Hydroxymethylglutaryl-CoA Reductase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M351

- Name: Atorvastatin

- Relevance: HIGH

- As Found: 1 year

- ID: M21155

- Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4243

- Name: Anticholesteremic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4278

- Name: Hypolipidemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M28883

- Name: Lipid Regulating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069059

- Term: Atorvastatin

### Misc Info Module

- Version Holder: 2024-05-24
