Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00151788
Other study ID # 505-205
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received September 7, 2005
Last updated January 16, 2012
Start date February 2004
Est. completion date March 2006

Study information

Verified date January 2012
Source Daiichi Sankyo Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.


Recruitment information / eligibility

Status Terminated
Enrollment 796
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- Confirmed diagnosis of heterozygous familial hypercholesterolemia

- Ambulatory male (40 to 75 years, inclusive) or female (45 to 75 years, inclusive) subjects

- Calculated LDL-C level greater than or equal to 100 mg/dL (or 2.5 mmol/L) and triglycerides less than 500 mg/dL (5.65 mmol/L) while on usual and stable lipid-lowering therapy

Exclusion Criteria:

- Breast feeding or lactating women

- Previous organ transplantation

- High-grade stenosis (>75%) or the occlusion of any segment of either carotid artery

- History of carotid endarterectomy, or insertion of carotid artery stent or are scheduled to have either of these procedures

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Pactimibe sulfate


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Daiichi Sankyo Inc.

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Netherlands,  Norway,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis.
Secondary To assess the effects of pactimibe versus placebo, when added to usual medical care:
Secondary - on the incidence and the time to first occurrence of
Secondary cardiovascular events,
Secondary - on inflammatory and oxidative markers, such as serum
Secondary high-sensitivity C-reactive protein (hsCRP), plasma
Secondary interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and
Secondary serum nitrotyrosine.
Secondary To compare the safety of pactimibe versus placebo, when added to usual medical care, particularly with respect to the incidence of clincal and laboratory adverse events.
See also
  Status Clinical Trial Phase
Recruiting NCT05052918 - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes N/A
Recruiting NCT04511234 - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease N/A
Completed NCT05906797 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis. N/A
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Suspended NCT02932176 - Machine Learning for Handheld Vascular Studies
Recruiting NCT05158257 - Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity N/A
Completed NCT01212900 - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression Phase 4
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Recruiting NCT06230406 - T-Mem GEne in Atherosclerosis
Completed NCT03654313 - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus Phase 1
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Recruiting NCT02894931 - Effects of Dietary Interventions on Serum and Macrophage Atherogenicity N/A
Completed NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A
Recruiting NCT02265250 - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Completed NCT03393377 - Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination N/A
Completed NCT02224339 - New Technologies to Determine Carotid Plaque Vulnerability
Completed NCT02268513 - Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
Not yet recruiting NCT01923012 - Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis Phase 2
Completed NCT02377310 - Pd/Pa vs iFRâ„¢ in an Unselected Population Referred for Invasive Angiography N/A