Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00689442 |
Recruitment Status
:
Completed
First Posted
: June 3, 2008
Last Update Posted
: June 3, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dyslipidemia | Drug: JTT-705 600 mg and atorvastatin 20 mg Drug: Placebo and atorvastatin 20 mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 105 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Atorvastatin 20 mg in Patients With Low HDL Levels |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | November 2004 |
Actual Study Completion Date : | March 2006 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
JTT-705 600 mg and atorvastatin 20 mg
|
Drug: JTT-705 600 mg and atorvastatin 20 mg
|
Placebo Comparator: 2
Placebo and atorvastatin 20 mg
|
Drug: Placebo and atorvastatin 20 mg
|
- % change from baseline in HDL-C; inhibition of CETP activity [ Time Frame: 4-weeks ]
- % change from baseline in LDL-C and TC/HDL-C [ Time Frame: 4-weeks ]
- Plasma concentration of JTT-705 [ Time Frame: 4-weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689442
Netherlands | |
Amsterdam, Netherlands |
Responsible Party: | Shoji Hoshino, DVM, Vice President, Clinical Development, Akros Pharma Inc. |
ClinicalTrials.gov Identifier: | NCT00689442 History of Changes |
Other Study ID Numbers: |
AT705-X-03-002 |
First Posted: | June 3, 2008 Key Record Dates |
Last Update Posted: | June 3, 2008 |
Last Verified: | May 2008 |
Additional relevant MeSH terms:
Dalcetrapib Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Calcium Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |