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A Safety and Efficacy Study of DRL-17822, a Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Patients With Abnormal Cholesterol 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. Identifier: NCT01388816
Recruitment Status : Completed
First Posted : July 7, 2011
Results First Posted : April 22, 2014
Last Update Posted : April 22, 2014
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for heart disease.

Condition or disease Intervention/treatment Phase
Type II Hyperlipidemia Drug: DRL-17822 or placebo Phase 2

Detailed Description:

Cardiovascular disease is a leading cause of death worldwide. Among cardiovascular disorders, coronary heart disease (CHD) caused by atherosclerosis is the most common cause of morbidity and mortality. Prevention, stabilization and regression of atherosclerotic plaques may have a major impact on reducing the risk of acute coronary events.

LDL-C lowering agents, primarily the statins, are the current mainstay in the pharmacologic management of dyslipidemia. However even with stain use, residual CHD risk from dyslipidemia remains. Epidemiologic and observational studies have shown that HDL-C is also a strong independent predictor of CHD, suggesting that raising HDL-C levels might afford clinical benefit in the reduction of cardiovascular risk.

Presently only niacin is approved by the FDA for HDL-C elevation and can raise HDL-C levels by 20-30%. However its use can be limited by a high incidence of flushing and, less commonly, by elevation of blood glucose and potential hepatic toxicity.

Cholesteryl ester transfer protein (CETP) inhibitors are being explored for their ability to elevate HDL-C. A small molecule CETP inhibitor, torcetrapib, has been demonstrated to elevate HDL-C by 60-100%. However, a large clinical trial (ILLUMINATE) where it increased HDL-C by a mean of 72% compared to baseline was halted as it failed to show benefit. Post-hoc analysis of this study implicated an off-target increase in blood pressure as potentially counteracting any anti-atherosclerotic benefits. Post-hoc subgroup analysis showed that patients in the highest HDL-C quartile had a 57% reduction in the risk of cardiovascular events.

Increased blood pressure appears to be specifically related to torcetrapib as two other small molecule CETP inhibitors, anacetrapib and dalcetrapib, have not shown this in clinical trials and have been well tolerated. DRL-17822 has also not shown elevation of blood pressure in either animals or in normal volunteers.

This study will investigate the efficacy and tolerability of DRL-17822 as dyslipidemia monotherapy in patients with Type II hyperlipidemia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of DRL-17822 in Patients With Type II Hyperlipidemia
Study Start Date : July 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo capsule Drug: DRL-17822 or placebo
DRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast

Experimental: DRL-17822 50 mg Drug: DRL-17822 or placebo
DRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast

Experimental: DRL-17822 150 mg Drug: DRL-17822 or placebo
DRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast

Experimental: DRL-17822 300 mg Drug: DRL-17822 or placebo
DRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast

Primary Outcome Measures :
  1. Percent Change in HDL-C From Baseline [ Time Frame: 28 days ]
    Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia

Secondary Outcome Measures :
  1. Safety and Tolerability of DRL-17822 [ Time Frame: 28 days ]
    Incidence of treatment-related adverse events

  2. Changes in Vital Signs Including Blood Pressure [ Time Frame: 28 days ]
    Vital sign abnormalities reported as treatment-emergent AEs

  3. To Evaluate Trough Levels of DRL-17822 in Plasma [ Time Frame: 28 days ]
    Trough levels of DRL-17822 in plasma after 28 days of treatment

  4. Changes in CETP Inhibition in Plasma [ Time Frame: 28 days ]
    Percent change from baseline in CETP Inhibition

  5. Changes in Other Lipids and Apolipoproteins [ Time Frame: 28 days ]
    Change from baseline (LOCF, ITT population)

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with Type II hyperlipidemia having lipid values of HDL-C: males ≤ 44 mg/dL (≤1.13 mmol/L), females ≤ 54 mg/dL (≤1.39 mmol/L); LDL-C: ≥ 130 mg/dL (≥3.33 mmol/L);
  • Male or female, 18 to 70 years of age, inclusive. Female patients must be postmenopausal or surgically sterile. Men, unless surgically sterile must practice birth control from screening until the end of the study;
  • Ability and willingness to give written informed consent;
  • No clinically significant abnormal findings on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory profiles of both blood and urine.

Exclusion Criteria:

  • Patients with significant cardiac disease such as myocardial infarction, heart failure, coronary or peripheral artery angioplasty, bypass graft surgery, severe or unstable angina pectoris, cardiac arrhythmias, hypertension or any other disease which requires treatment;
  • Uncontrolled diabetes (HbA1c > 8.0%);
  • History of symptomatic cerebrovascular disease such as symptomatic carotid artery disease, cerebrovascular hemorrhage, transient ischemic attack or carotid endarterectomy or any disease which requires treatment;
  • History of clinically significant hematologic, renal, hepatic, neurologic, endocrine, oncologic, pulmonary, immunologic or psychiatric disorders;
  • Any current or recent (within 4 weeks of run-in) concomitant therapy (apart from paracetamol/acetaminophen and non-steroidal anti-inflammatory drugs [NSAIDs]). Patients on previous concomitant treatment may enter the study if the treatment has been discontinued, when appropriate and if ethically justified, at least four weeks prior to run-in;
  • Body mass index (BMI)> 35 kg/m(2);
  • Positive for hepatitis B, C or HIV or known history or concurrent tuberculosis;
  • Positive drug screen result (i.e., cocaine, opiates, amphetamine, cannabis, barbiturates, benzodiazepines and/or metadone);
  • Pregnant, breast feeding or women of child-bearing potential;
  • Regular use of non-drug therapies such as garlic supplements and St. John's Wort;
  • Presence or history of alcoholism or drug abuse;
  • Use of more than 21 units of alcohol per week for males or more than 14 units per week for females;
  • Smoking within 3 months prior to screening;
  • Relevant drug hypersensitivity or allergy or any serious adverse event reaction to lipid regulating agents;
  • Administration of study drug in another drug study within 90 days prior to enrollment or participation in another drug trial from screening to last follow-up of this study; Any surgical or medical condition which makes the patient unsuitable to participate in the opinion of the Investigator.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01388816

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Genova, Italy
Milano, Italy
Modena, Italy
Palermo, Italy
Perugia, Italy
Gdynia, Poland
Gniewkowo, Poland
Katowice, Poland
Wroclaw, Poland
Chernivtsi, Ukraine
Kharkov, Ukraine
Kyiv, Ukraine
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
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Study Director: Kent Allenby, MD Dr. Reddy's Laboratories
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Responsible Party: Dr. Reddy's Laboratories Limited Identifier: NCT01388816    
Other Study ID Numbers: DRL-17822/CD/004
First Posted: July 7, 2011    Key Record Dates
Results First Posted: April 22, 2014
Last Update Posted: April 22, 2014
Last Verified: March 2014
Keywords provided by Dr. Reddy's Laboratories Limited:
Placebo Controlled
Parallel Arm
Type II Hyperlipidemia
Cholesteryl Ester Transferase Protein Inhibitor
CETP Inhibitor
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn