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CompletedNCT00688558Updated Jun 3, 2008

Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

A Phase 2 interventional study of JTT-705 600 mg and simvastatin 40 mg and Placebo and simvastatin 40 mg in Dyslipidemia, sponsored by Akros Pharma Inc.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-06-03.

Sponsored by Akros Pharma Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with simvastatin 40 mg in patients with low HDL

02

Conditions studied

  • Dyslipidemia

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03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 92 is close to the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Akros Pharma Inc. is the lead sponsor of 25 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients having lipid values as indicated below:
  • HDL-C ≤ 1.0 mmol/L (40 mg/dL)
  • TG ≤4.5 mmol/L (400 mg/dL)
  • Patients with CHD or CHD risk equivalent
  • Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)

Exclusion criteria

Exclusion Criteria:

  • Body Mass Index of ≥ 35 kg/m2
  • Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception
  • Concomitant use of medications identified in the protocol
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    1

    JTT-705 600 mg and simvastatin 40 mg

    Drug: JTT-705 600 mg and simvastatin 40 mg

  • Placebo comparator
    2

    Placebo and simvastatin 40 mg

    Drug: Placebo and simvastatin 40 mg

Interventions

  • DrugJTT-705 600 mg and simvastatin 40 mg

    * JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment * Simvastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, immediately following breakfast and/or assessments

  • DrugPlacebo and simvastatin 40 mg

    * Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments * Simvastatin 40 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments

06

What researchers measure

Primary outcomes

  1. % change from baseline in HDL-C; inhibition of CETP activity

    Time frame: 4-weeks

Secondary outcomes

  1. % change from baseline in LDL-C and TC/HDL-C

    Time frame: 4-weeks

  2. Plasma concentration of JTT-705

    Time frame: 4-weeks

07

Study locations

1 site
  • Amsterdam, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00688558
Lead sponsor
Akros Pharma Inc.
First posted
Jun 3, 2008
Start date
Feb 2004
Primary completion
Dec 2004
Completion
Mar 2006
Last update
Jun 3, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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