NCT00216463

Brief Summary

The aim of this study is to assess the safety and tolerability of varying dose and load regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

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

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

September 19, 2005

Last Update Submit

August 1, 2016

Conditions

Hypercholesterolemia

Keywords

LDL-cholesterolapoB-100apoB-48

Outcome Measures

Primary Outcomes (1)

  • Percent reduction in LDL-cholesterol from baseline

    14 days post dosing

Secondary Outcomes (3)

  • Percent reduction in apoB-100 from baseline

    14 days post dosing

  • Percent change from baseline in HDL-cholesterol, triglycerides, total cholesterol, non-HDL cholesterol, VLDL and LP(a)

    14 days post dosing

  • Percent change from baseline in LDL/HDL and apoB-100/apo-A1 ratios

    14 days post dosing

Study Arms (5)

A

EXPERIMENTAL

Slow load with every other week maintenance

Drug: ISIS 301012 or Placebo

B

EXPERIMENTAL

Slow load with every other week maintenance

Drug: ISIS 301012 or Placebo

C

EXPERIMENTAL

No load; once weekly maintenance

Drug: ISIS 301012 or Placebo

D

EXPERIMENTAL

No load; once weekly maintenance

Drug: ISIS 301012 or Placebo

E

EXPERIMENTAL

No load; once weekly maintenance

Drug: ISIS 301012 or Placebo

Interventions

ISIS 301012 or PlaceboDRUG

200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 200 mg subcutaneous injection - every other week for 11 weeks

A

Eligibility Criteria

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

You may qualify if:

  • BMI \>/= 25 to \</= 32 kg/m\^2
  • fasting stable LDL-cholesterol \>/= 130 mg/dL (3.36 mmol/L) and triglycerides \< 400 mg/dL (4.55 mmol/L)
  • Females not of childbearing potential

You may not qualify if:

  • No endocrine, hematologic, renal, hepatic, metabolic, psychiatric, neurology, pulmonary or cardiovascular disease
  • Subjects who test positive for hepatitis B, C or HIV
  • Current diagnosis or known history of liver disease, such as acute or chronic hepatitis, liver cirrhosis, liver steatosis, or liver function abnormalities such as AST, ALT, GGT, or total bilirubin \>/= 1.5 x ULN at Screening
  • A systolic blood pressure \>/= 160 mmHg or a diastolic blood pressure \>/= 95 mmHg on 2 occasions during Screening
  • Concomitant medications within 14 days of dosing, except hormone replacement therapy for post-menopausal women and acetylsalicylic acid or paracetamol dosed for fewer than five consecutive days
  • Subject has taken any lipid-lowering drug within 30 days or five half-lives (of the lipid-lowering drug) whichever is longer, prior to Screening
  • Alcohol or drug abuse within 2 years of Screening
  • Donated blood (450 mL) within the 3 months prior to Screening or suffered significant blood loss equal to a blood donor portion
  • Subject smokes \> 10 cigarettes, or more than one pipe or one cigar per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, D-14050, Germany

Location

Related Publications (1)

  • Akdim F, Tribble DL, Flaim JD, Yu R, Su J, Geary RS, Baker BF, Fuhr R, Wedel MK, Kastelein JJ. Efficacy of apolipoprotein B synthesis inhibition in subjects with mild-to-moderate hyperlipidaemia. Eur Heart J. 2011 Nov;32(21):2650-9. doi: 10.1093/eurheartj/ehr148. Epub 2011 May 18.

    PMID: 21593041DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

mipomersen

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    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

September 19, 2005

First Posted

September 22, 2005

Study Start

August 1, 2005

Primary Completion

March 1, 2007

Study Completion

August 1, 2007

Last Updated

August 3, 2016

Record last verified: 2016-08

Locations

DE(1)