Single dose study in adolescents with High cholesterol

• Conditions: Heterozygous Familial Hypercholesterolaemia; MedDRA version: 14.1Level: PTClassification code 10058108Term: DyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10057099Term: Heterozygous familial hypercholesterolaemiaSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001443-49-GB
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-15
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Demographics1. Patient is a male or female post-pubertal adolescent subject of age 10-16 with heterozygous familial hypercholesterolemia Males: Tanner stage II or higher Females: Post-menarche (defined as at least 1 year after the first menstrual period and having had at least 3 menstrual periods) 2. Patients height and weight fall between the 10th and 95th percentile for age with a minimum body weight of 23Kg at the screening visit Protocol-specific Inclusion Criteria 3. The patient has LDL-C values = 110mg/dL (2.85mmol/L) and =400mg/dL (10.3mmol/L) 4. Patient trigleride (TG) values =400mg/dL (4.52mmol/L) 5. Patient has heterozygous familial hypercholesterolemia Medical history, physical examinations, laboratory safety tests and ECG measurements 6. Patient receives appropriate medical care for their hypercholesterolemia, such as a statin or other lipid modifying therapy. Patients on a statin or any other lipid modifying therpay must be on a stable regimen for 6 weeks prior to the screening visit. 7. Glycemic status of the patient has been determined prior to randomisation 8. Patient is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the prestudy and/or prior to administration of the initial dose of study drug 9. Patient has no clinically significant abnormality on ECG performed at the prestudy visit and/or prior to administration of the initial dose of study drug Diet/Activity/Other 10. Parent/legal guardian and patient understand the study procedures and agree to participate in the study as indicated by parental/legal guardian signature on the subject consent 11. Patient is willing to comply with the study restrictions
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Medical history, physical examinations, laboratory safety tests and ECG measurements 1. Patient with a history of psychiatric or personality disorders that in the opinion of the investigator and sponsor, affects the patient's ability to participate in the trial 2. Patient has a history of any illness that in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the patient by their participation in the study. 3. Patient has an estimated creatinine clearance of =80ml/min based on the Schwartz equation, the Schwartz equation is: CrCl (ml/min) = length(cm) X K/Scr(mg/dL) where K = 0.55 for all children 1 to 12 years, K=0.55 for females age 13 to 18 years and K=0.7 for males age 13 to 18 years. 4. Patient has a history of stroke, chronic seizures or major neurological disorder 5. Patient has a history of clinically significant endocrine, gastrointestinal cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding lipid abnormalities). Patients with a history of uncomplicated kidney stones or childhood asthma may be enrolled in the study at the discretion of the investigator. 6. Patient has Type 1 or Type 2 diabetes mellitus and: - is poorly controlled (HbA1C at Visit 1 >8%) or is newly diagnosed (within 3 months of Visit 1) - has recently experienced repeated hypoglycemia or unstable glycemic control. - is taking new or recently adjusted anti-diabetic pharmacotherapy (with the exception of ± 10 units of insulin) within 3 months of Visit 1. 7. Patient has a history of neoplastic disease within 5 years from screening Exceptions: (1) Patients with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the study; (2) Patients with other malignancies which have been successfully treated 10 years prior to the prestudy (screening) visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the prestudy (screening) visit (except those cancers identified at the beginning of exclusion criterion f); or, (3) Patients, who, in the opinion of the study investigator, are highly unlikely to sustain a recurrence for the duration of the study. Diet/Activity/Other 8. Patient has LDL-C < 160 mg/dL ( 4.1 mmol/L) after dietary treatment 9. Patient consumes alcohol. 10. Patient consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of cola, coffee, tea, or other caffeinated beverages per day. 11. Patient has had major surgery, donated and/or received blood as follows: - Donated blood products or lost >300 mL within 8 weeks prior to signing the consent form - Intends to give or receive blood products during the study - Intends to donate more than 250 mL of blood products within 8 weeks following the follow-up visit 12. Patient has participated in another investigational study within 4 weeks prior to the prestudy (screening) visit. The 4 week window will be derived from the date of the last study procedure (i.e. poststudy, AE follow-up, etc.) in the previous study to the prestudy/screening visit of the current study. 13. Patient has a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescriptio

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified