Clinical Trials

Pfizer sponsored numerous late-stage Phase 3 clinical trials evaluating torcetrapib, both alone and in combination with statin therapy, for metabolic and cardiovascular conditions including hyperlipidemia, dyslipidemia, coronary disease, and diabetes mellitus. Although several clinical trials reached completion, key studies were terminated early due to adverse safety outcomes, specifically increased cardiovascular events and mortality.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00134264 TERMINATED
Coronary Disease; Diabetes Mellitus
Pfizer
2004-07 PHASE3
NCT00267280 TERMINATED
Hyperlipidemia; Dyslipidemia; Hypercholesterolemia
Pfizer
2006-01 PHASE3
NCT00145431 TERMINATED
Hyperlipoproteinemia Type III
Pfizer
2005-03 PHASE3
NCT00134238 TERMINATED
Mixed Hyperlipidemia
Pfizer
2003-11 PHASE3
NCT00138762 COMPLETED
Hyperlipidemia
Pfizer
2004-07 PHASE3
NCT00139061 Completed
Hyperlipidemia
Pfizer
2005-03 Phase 3
NCT00267254 COMPLETED
Hyperlipidemia; Dyslipidemia; Hypercholesterolemia
Pfizer
2006-01 PHASE3
NCT00134173 COMPLETED
Coronary Disease; Coronary Arteriosclerosis; Hyperlipidemia
Pfizer
2003-10 PHASE3
NCT00139061 COMPLETED
Hyperlipidemia
Pfizer
2005-03 PHASE3
NCT00134498 COMPLETED
Hypertriglyceridemia; Hyperlipoproteinemia Type IV
Pfizer
2005-02 PHASE3
NCT00267267 TERMINATED
Hyperlipidemia; Dyslipidemia
Pfizer
2006-01 PHASE3
NCT00137462 COMPLETED
Hyperlipidemia
Pfizer
2004-11 PHASE3
NCT00134511 COMPLETED
Hypercholesterolemia, Familial
Pfizer
2005-03 PHASE3
NCT00134485 COMPLETED
Hypercholesterolemia, Familial; Hyperlipidemia
Pfizer
2005-03 PHASE3
NCT00136981 COMPLETED
Hypercholesterolemia, Familial; Hyperlipidemia
Pfizer
2003-12 PHASE3

(data from https://clinicaltrials.gov, updated on 2012-02-03)

Check the Torcetrapib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Torcetrapib is a potent inhibitor of cholesterylester transfer protein (CETP) that binds directly to the enzyme and blocks the transfer of cholesteryl esters from high-density lipoproteins (HDL) to low-density and very-low-density lipoproteins (LDL/VLDL). This inhibition elevates plasma HDL-cholesterol levels and reduces pro-atherogenic non-HDL cholesterol, which directly targets the lipid imbalances associated with hyperlipidemia, dyslipidemia, and coronary artery disease evaluated in late-stage clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.