Efficacy Study of Pioglitazone and Atorvastatin Combination Therapy in Treating Subjects With Elevated Risk for Cardiovascular Disease

NCT00770575 | Completed Phase 2

• 4 other identifiers: ATS K0152004-004463-30D-PIO-106U1111-1115-9124
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and atorvastatin combination therapy compared to atorvastatin monotherapy in patients at risk for cardiovascular disease.

Conditions

Cardiovascular Diseases

Keywords

Biological Markers; Biochemical Markers; Carotid Artery, Internal; Carotid Artery, Common; Marker, Surrogate; Vascular Diseases; Diabetes Mellitus; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change in the intima-media thickness of the common carotid artery.

  Week 24.

Secondary Outcomes (11)

• Change in the intima-media thickness of the internal carotid artery.

  Week 24.

• Change in the intima-media thickness of the carotid bulbus.

  Week 24.

• Change from Baseline in Efficacy Laboratory findings (Interleukin-6, high sensitive C reactive peptide and monocyte chemotactic protein-1)

  Week: 24.

• Change from Baseline in Efficacy Laboratory findings (matrix metalloproteinase-9, soluble CD40 Ligand, P-Selectin, soluble intracellular adhesion molecule 1 and soluble vascular cell adhesion molecule 1).

  Week: 24.

• Change from Baseline in Efficacy Laboratory findings (adiponectin, tissue plasminogen activator, Plasma glucose, Insulin and Intact proinsulin).

  Week: 24.

Study Arms (2)

Pioglitazone 30mg to 45 mg QD + Atorvastatin 20 mg to 40 mg QD

EXPERIMENTAL

Drug: Pioglitazone and atorvastatin

Atorvastatin 20mg to 40 mg QD

ACTIVE COMPARATOR

Drug: Atorvastatin

Interventions

Pioglitazone and atorvastatin DRUG

Pioglitazone 30 mg, capsules, orally, once daily and atorvastatin 20 mg, tablets, orally, once daily for 4 weeks; increase to: Pioglitazone 45 mg, capsules, orally, once daily and atorvastatin 40 mg, tablets, orally, once daily for up to 20 weeks.

Also known as: ACTOS®, AD4833

Pioglitazone 30mg to 45 mg QD + Atorvastatin 20 mg to 40 mg QD

Atorvastatin DRUG

Pioglitazone placebo-matching capsules, orally, once daily and atorvastatin 20 mg, tablets, orally, once daily for 4 weeks; increased to Pioglitazone placebo-matching capsules, orally, once daily and atorvastatin 40 mg, tablets, orally, once daily for up to 20 weeks.

Atorvastatin 20mg to 40 mg QD

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intima-media thickness of Common Carotid Artery greater than or equal to 0.8 mm (at least on one side).
• Increased cardiovascular risk defined as one or more of the following:
• medical history of infarction
• coronary angiography with proven cardiovascular disease
• instable Angina pectoris
• duplex-sonography of cervical or leg vessels with proven atherosclerotic vascular alterations
• electrocardiogram with ischemia
• stroke
• transient ischemic attack
• peripheral arterial occlusion
• vessel surgery
• hypertension (RR greater than 140/90)
• antihypertensives
• high density lipoprotein less than 40 mg/dl.
• Body mass index greater than or equal to 25 kg/m2.

You may not qualify if:

• History of overt type-2-diabetes according to the World Health Organization criteria.
• History of type-1-diabetes.
• History of more than one unexplained hypoglycemic episode within the last 6 months.
• Statin therapy within the last 4 weeks.
• Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
• History of severe or multiple allergies.
• Treatment with any other investigational drug within 3 months before trial entry.
• Progressive fatal disease.
• Myopathy.
• Drug or alcohol abuse within the last 5 years.
• Smoker defined as patient with evidence or history of tobacco or nicotine use within the last 6 months before the screening visit.
• A history of heart failure (New York Heart Association stage II - IV) or significant respiratory, gastrointestinal, hepatic (glutamate-pyruvate-transaminase time greater than 2.5 times the normal reference range), renal (creatinine greater than 2.0 mg/dl) or hematological disease.
• Blood donation within the last 30 days.
• Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• ciclosporin

Sponsors & Collaborators

• Takeda: lead

Related Links

• ACTOS® Package Insert

MeSH Terms

Conditions

Cardiovascular Diseases; Vascular Diseases; Diabetes Mellitus

Interventions

Pioglitazone; Atorvastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Head of Clinical Research/Licensing/New Products

  Takeda Pharma Gmbh, Aachen (Germany)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: June 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: July 5, 2010

Record last verified: 2010-07