NCT00134511

Brief Summary

The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients with genetically known disorder of extremely high cholesterol

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_3

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

November 7, 2007

Status Verified

December 1, 2006

First QC Date

August 22, 2005

Last Update Submit

November 5, 2007

Conditions

Hypercholesterolemia, Familial

Outcome Measures

Primary Outcomes (1)

  • Change in LDL-C and HDL-C

Secondary Outcomes (1)

  • Other lipid variables

Interventions

Torcetrapib/atorvastatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Homozygous Familial Hypercholesterolemia

You may not qualify if:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
  • Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Pfizer Investigational Site

Ste-Foy, Quebec, G1V 4M6, Canada

Location

Pfizer Investigational Site

Parktown, Johannesburg, 2193, South Africa

Location

Pfizer Investigational Site

Bloemfontein, 9301, South Africa

Location

Pfizer Investigational Site

Cape Town, 7925, South Africa

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

torcetrapibAtorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

March 1, 2005

Study Completion

November 1, 2005

Last Updated

November 7, 2007

Record last verified: 2006-12

Locations

ZA(3)US(1)CA(2)