Hyperlipidemia Type II MedDRA version: 14.1 Level: PT Classification code 10045254 Term: Type II hyperlipidaemia System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Product Name: DRL-17822
Product Code: DRL-17822
Pharmaceutical Form: Capsule
CAS Number: 898911-09-6
Current Sponsor code: DRL-17822
Other descriptive name: CZ0L3
Concentration unit: mg milligram(s)
C
Sponsors
DR. REDDY'S LABORATORIES LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with Type II hyperlipidaemia having lipid values as indicated below: - 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); 2. Male or female, 18 to 70 years of age, inclusive. Female patients must be post-menopausal or surgically sterile. Post-menopausal is defined as being amenorrhoeic for at least 24 consecutive months and a follicle stimulating hormone (FSH) level =30 IU/L; Men, unless surgically sterile, must practice two effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Screening until the end of the study 3. Ability and willingness to give written informed consent; 4. No clinically significant abnormal findings on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory profiles of both blood and urine Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: 1.Patients with a significant cardiac disease prior to enrollment, such as myocardial infarction, heart failure, coronary or peripheral artery angioplasty, bypass graft surgery, severe or unstable angina pectoris, cardiac arrthymias, hypertension or any other disease which requires treatment; 2.Uncontrolled diabetes (HbA1c >8.0%); 3.History of symptomatic cerebrovascular disease prior to enrollment, such as symptomatic carotid artery disease, cerebrovascular hemorrhage, transient ischemic attack or carotid endarterectomy or any disease which requires treatment; 4.History of clinically significant hematologic, renal, hepatic, neurologic, endocrinal, oncologic, pulmonary, immunologic or psychiatric disorders; 5.Any current or recent (within four weeks of Visit 2 [Start of Placebo run-in period [Day -14]) concomitant therapy (apart from paracetamol and 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 Visit 2 (Wash-out period to be performed prior to enter in the Run-in period); 6.Body Mass Index (BMI) > 35 kg/m²; 7.Positive for hepatitis B, C, or HIV and known history or current TB; 8.Positive drug screen result (i.e. cocaine, opiates, amphetamine, cannabis, barbiturates, benzodiazepines, and/or methadone); 9.Pregnant, breast feeding, or women with child-bearing potential; 10.Regular use of non-drug therapies such as garlic supplement and St John’s Wort; 11.Presence or history of alcoholism or drug abuse; 12.Use of more than 21 units of alcohol per week for males or more than 14 units of alcohol per week for females or more than four (men) or three (women) units in any one day (1 alcohol unit is equal to 25 ml of vodka, 85 ml of wine, 284 ml light beer approximately); 13.Smoking (10 or more cigarettes a day) within 3 months prior to screening; 14.Relevant drug hypersensitivity or allergy or any serious adverse reaction to lipid regulating agents; 15.Administration of study drug in an investigational drug study within 90 days prior to enrollment and participation in another drug trial from Screening until Follow-up; 16.Any surgical or medical condition which can make unsuitable the patient to participate in the study in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of DRL- 17822 in patients with Type II hyperlipidemia;Secondary Objective: •To evaluate the safety and tolerability of DRL- 17822 in patients with Type II hyperlipidemia •To evaluate changes in vital signs including blood pressure in this population •To measure trough levels of DRL- 17822 in plasma •To evaluate changes in CETP inhibition in the plasma with DRL-17822 •To evaluate changes in lipids and apolipoproteins Exploratory: •To measure serum aldosterone and cortisol levels;Primary end point(s): Percentage change in HDL-C from baseline (Visit 3) to end of double-blind treatment (Visit 6);Timepoint(s) of evaluation of this end point: From Visit 3 to the end of double-blind treatment (Visit 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Percent change from baseline in TC, LDL-C, HDL C/LDL-C ratio, triglycerides and apolipoproteins (Apo A-I, Apo-B, Apo-E and Lp(a)). •Percentage of inhibition of CETP;Timepoint(s) of evaluation of this end point: Visit 6 | — |
Countries
Italy, Ukraine
Contacts
Public ContactRegulatory Operations Europe
PHARMANET Ltd.
Outcome results
None listed