anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: rhEPO
Trial phase: Phase 4
SMILES: COC1C(O)CC(=O)OC(C)CC=CC=CC(OC2CC(C)(O)C(O)C(C)O2)C(C)CC(CCO)C1OC1OC(C)C(OC2CC(C)(O)C(O)C(C)O2)C(N(C)C)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
Eligibility criteria:
Inclusion Criteria: - Scheduled to undergo elective major abdominal and/or pelvic surgery with anticipated significant perioperative ((the time period describing the duration of a participants surgical procedure) blood loss (eg, greater than 500 cc and at increased risk for blood transfusion) - Hemoglobin greater than 10 g/dL and less than or equal to 13 g/dL at screening (Day -13 [13 days prior to surgery] to Day -11) and baseline (Day -10) - Patients with reproductive potential and their partners must practice an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, partner sterilization) before entry and throughout the study - Female patients with reproductive potential must have a negative urine pregnancy test within 7 days of the first dose of PROCRIT - Adequate renal (kidney) and adequate hepatic (liver) function assessed within the 21-day screening period Exclusion Criteria: - No severe Congestive Heart Failure (New York Heart Association Class IV) - No known severe stable or unstable coronary artery disease, or unstable angina - No history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 12 months before study entry (prior superficial thrombophlebitis is not an exclusion criterion) - No history of cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute coronary syndrome (unstable Angina, myocardial Infarction), or other arterial thrombosis within 6 months before study entry - Not anticipated to donate perioperative autologous blood or receive transfusions within 21 days prior to baseline or to have greater than 6 transfusions perioperatively - No prior treatment with PROCRIT or any erythropoiesis-stimulating agents (ESAs) within the previous month
Intervention: Clonidine
Trial phase: Phase 2
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
Eligibility criteria:
Inclusion Criteria:

Healthy adult volunteers
Patients with neuropathic pain

Exclusion Criteria:

Pregnancy
Allergy to clonidine
Currently taking clonidine or other direct a2-adrenergic agonists
Taking cholinesterase inhibitors
Intervention: Testosterone
Trial phase: Phase 4
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: androgel 5g

androgel: androgel 5g
Eligibility criteria:
Inclusion Criteria:

Males with age 35-75 years inclusive.
Evidence of hypogonadism: low free testosterone.
Type 2 Diabetes
People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.
If currently on testosterone replacement,testosterone treatment will be held for 8 weeks.
BP under control even if on medication.

Exclusion Criteria:

Coronary event or procedure in previous past 4 wks.
High PSA
H/O prostate cancer
Hepatic or renal disease
Participation in any other concurrent clinical trial
Any other life- threatening , non cardiac disease.
Uncontrolled BP
Congestive heart failure
High hemoglobin
Use of investigational agent or therapeutic regimen within 30 days of study.
Intervention: Testosterone
Trial phase: Phase 4
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: androgel 10g

androgel 10g: androgel 10g
Eligibility criteria:
Inclusion Criteria:

Males with age 35-75 years inclusive.
Evidence of hypogonadism: low free testosterone.
Type 2 Diabetes
People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.
If currently on testosterone replacement,testosterone treatment will be held for 8 weeks.
BP under control even if on medication.

Exclusion Criteria:

Coronary event or procedure in previous past 4 wks.
High PSA
H/O prostate cancer
Hepatic or renal disease
Participation in any other concurrent clinical trial
Any other life- threatening , non cardiac disease.
Uncontrolled BP
Congestive heart failure
High hemoglobin
Use of investigational agent or therapeutic regimen within 30 days of study.
Intervention: Hydroxyurea
Trial phase: Phase 1 | Phase 2
ATC code: L01XX05
SMILES: NC(=O)NO
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
Eligibility criteria:
Inclusion Criteria:

Age between 10 and 25 years old
Sickle cell disease with hemoglobin SS, SC or S-B^0 thalassemia confirmed on hemoglobin electrophoresis
Tricuspid regurgitant jet velocity (TRJV) equal to or greater than 2.5 m/sec on 2 baseline Doppler echocardiograms at least 3 months apart

Exclusion Criteria:

Patients already being treated with hydroxyurea
Patients on a chronic transfusion protocol
Patients with evidence of hepatic (alanine aminotransferase [ALT] equal to or greater than 2 SD above normal) or renal dysfunction (creatinine [Cr] equal to or greater than 2 SD above normal)
Patients who are pregnant
Patients with documented causes of severe pulmonary hypertension other than from SCD
Intervention: Ziprasidone
Trial phase: Phase 4
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
Ages 18-65 years
Capable of providing informed consent
Antipsychotic Agents -associated diabetes mellitus, impaired fasting glucose or insulin resistance
Stable dose of clozapine or olanzapine for at least 1 month
Optimal dose of clozapine or olanzapine, or a maximal dose if limited by significant side effects

Exclusion Criteria:

Serious medical or neurological illness (unstable cardiac disease including recent myocardial infarction or heart failure, seizure disorder, malignancy, liver or renal impairment, etc.)
Current substance abuse
Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
History of serious blood dyscrasia requiring discontinuation of clozapine
Serious suicidal or homicidal risk within the past six months
History of diabetes mellitus prior to treatment with clozapine or olanzapine
H/o prolongation of QTc interval (>450) on EKG or clinically significant EKG abnormalities.
Treatment with medications that significantly prolong QTc interval such as dofetilde, sotalol, quinidine, class Ia and III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacine, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyul acetate, dolasetron myselate, probucol, or tacrolimus.
Intervention: Linolenic Acid
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
Eligibility criteria:
Inclusion Criteria:

Requiring positive-pressure mechanical ventilation
ALI criteria: PaO2/FiO2 <300, bilateral infiltrates on chest radiograph, no left atrial hypertension
Age > 17 years

Exclusion Criteria:

Expected ICU length of stay <48 hours
Unable to undergo bronchoalveolar lavage at enrollment
Unable to obtain enteral access
Post-cardiac arrest with suspected significant anoxic brain injury
Expected survival < 28 days
Pregnant
Platelet count < 30,000, active bleeding, or international normalized ratio (INR)>3.0
History of ventricular tachycardia or fibrillation
Receiving recombinant human activated protein C (rh-APC) for sepsis
Acquired immune deficiency syndrome (AIDS) with CD4 count < 200
Metastatic cancer
History of bone marrow, lung, liver, cardiac, kidney, or pancreas transplant
Intervention: Linolenic Acid
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: 7.5cc 0.9% saline every 6 hours
Eligibility criteria:
Inclusion Criteria:

Requiring positive-pressure mechanical ventilation
ALI criteria: PaO2/FiO2 <300, bilateral infiltrates on chest radiograph, no left atrial hypertension
Age > 17 years

Exclusion Criteria:

Expected ICU length of stay <48 hours
Unable to undergo bronchoalveolar lavage at enrollment
Unable to obtain enteral access
Post-cardiac arrest with suspected significant anoxic brain injury
Expected survival < 28 days
Pregnant
Platelet count < 30,000, active bleeding, or international normalized ratio (INR)>3.0
History of ventricular tachycardia or fibrillation
Receiving recombinant human activated protein C (rh-APC) for sepsis
Acquired immune deficiency syndrome (AIDS) with CD4 count < 200
Metastatic cancer
History of bone marrow, lung, liver, cardiac, kidney, or pancreas transplant
Intervention: Testosterone
Trial phase: Phase 2
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Testosterone replacement therapy

Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
Eligibility criteria:
Inclusion Criteria:

Men
Age 18 years and older
Non-cancer chronic pain
Serum total testosterone level <350 ng/dl
Consumption of at least 20 mg of hydrocodone (or analgesic equivalent of another opioid) for at least 4 weeks
Absence of hospitalization in the past 2 months
No acute illness in the past 2 months
No current anabolic therapy (growth hormone, DHEA, etc)
No current use or consumption in the past 2 months of melatonin
Normal prostate exam
Normal PSA level

Exclusion Criteria:

Cancer-related chronic pain
Liver enzymes > 3 times upper limit of normal
Serum creatinine > 2 times upper limit of normal
Neurological disease
Active psychiatric illness
Any addictive drug use
Alcoholism (>3 drinks/day)
Patients currently receiving melatonin or anabolic agents
Hospitalization in the past 2 months
Acute illness in the past 2 months
Consumption of < 20 mg of hydrocodone (or analgesic equivalent of another opioid)
Severe BPH
PSA > 4.0 ng/ml
Prostate cancer
Breast cancer
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1767
Group description: Up to 10 weeks of open-label nicotine replacement therapy + counseling
Eligibility criteria:
Inclusion Criteria:

Subjects must be current residents of Ontario.
Older than or equal to 18 years of age.
Current daily smokers who smoke 10 or more cigarettes per day for at least 3 months.
Has smoked more than 100 cigarettes in their lifetime.

Exclusion Criteria:

Varenicline treatment, current.
Intolerant to nicotine replacement therapy (NRT)
Have a medical condition that would make participation medically hazardous as determined by the list of contraindications for NRT outlined in the Compendium of Pharmaceuticals and Specialties (CPS) and the NRT package insert, including a heart attack in the past two (2) weeks, life-threatening arrhythmias, severe or worsening angina pectoris, recent cerebro-vascular incident (past two (2) weeks)
Intervention: Mifepristone
Trial phase: Phase 2
ATC code: G03XB01 | G03XB51
SMILES: [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection
CD4 cell count > 200
Plasma HIV-1 RNA > 2000 copies/mL and have not received antiretroviral therapy within the 16 weeks prior to entry
Absolute neutrophil count > 750/mm3
Hemoglobin > 10 g/dL
Platelet count > 100,000 mm3
Creatinine < 2 X upper limit of normal [ULN] (fasting)
AST (SGOT), ALT (SGPT), and alkaline phosphatase < 2 X ULN
Total bilirubin < 2.5 X ULN
Albumin > 3 g/dL
Serum lipase < 1.5 X ULN
Thyroid stimulating hormone (TSH) within normal limits
Plasma cortisol > 20 mcg/dL, 30 minutes after cosyntropin administration
Negative pregnancy test and willing to use effective birth control during the study
Karnofsky performance score > 80 within 30 days prior to study entry
Men and women >= 18 years of age

Exclusion Criteria:

Receipt of antiretroviral treatment within the 16 weeks prior to study entry
Chronic adrenal failure, adrenal insufficiency, personal or family history of autoimmune endocrine disease, history of active hepatitis B or C, or current treatment for hepatitis B virus (HBV) or hepatitis C virus (HCV)
Presence of diabetes mellitus
Pregnancy within 90 days prior to study entry or breast-feeding
Dysfunctional uterine bleeding within the 12 months prior to study entry
Any current hormonal contraception or intrauterine device (IUD) use
Use of drugs that are inhibitors or inducers of metabolism by the cytochrome P450 3A4 within 7 days prior to study entry
Use of systemic corticosteroids or hormonal agents within 90 days prior to study entry
Use of any immunomodulator, HIV vaccines, or investigational therapy within 90 days prior to study entry
Any vaccination within 30 days prior to study entry
Use of systemic cytotoxic chemotherapy within 90 days prior to study entry
History of allergy to mifepristone or its formulations
Active drug or alcohol use
Serious illness requiring systemic treatment and/or hospitalization for at least 14 days prior to study entry
Weight < 40 kg or 88 lbs. within 90 days prior to study entry
Intervention: EXENATIDE
Trial phase: Phase 4
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.

Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

age 18-75
Type 2 Diabetes (diagnosed at least 3 months prior to study)
HbA1c: above 7.0 and less than or equal to 10.0
At least one HbA1c over preceding 3-6 months, and HbA1c at screening, with less than 1% difference between lowest and highest values
Stable doses of antidiabetic medications (SU and/or Metformin) for 3 months
reproductive age females must have negative urine HCG at screening, and be using appropriate contraception during the study or be surgically sterile
postmenopausal woman
stable weight for 3 months prior to study (+/- 2kg)
willingness to participate in the study

Exclusion Criteria:

Type 1 diabetes
Type 2 diabetes less than 3 months in duration
HbA1c less than 7.0 or greater than 10
age less than 18 or greater than 75
pregnant or planning to become pregnant during study period
current insulin therapy or insulin within 6 months prior to study
current use of Thiazolidinedione or within 6 months prior to study
current use of Nateglinide or Repaglinide
current use of an Alpha-glucosidase Inhibitor
current weight loss program
active smoker, or quit smoking within preceding 6 months
creatinine greater than 2.0 mg/dL
total cholesterol greater than 300 mg/dL
triglycerides greater than 600 mg/dL
blood pressure greater than 160/105 mmHg
ALT/AST greater than twice the upper limit of normal
any other medical condition that may interfere with trial participation or trial results
if on Statin: Statin therapy for less than 3 months or dose change within preceding 3 months
if on ACE Inhibitor: ACE Inhibitor therapy for less than 3 months or dose change within preceding 3 months
current use of any medication that is known to alter gastric motility
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
Eligibility criteria:
Inclusion Criteria:

Female Subjects able to give consent
Post partum patients
Baseline Hgb < /= 10 g/dL
Agree to practice birth control

Exclusion Criteria:

Participation in previous clinical trial of this investigational agent
Known hypersensitivity reaction to active control
Significant vaginal bleeding
History of anemia other than iron deficiency anemia
Anticipated need for surgery during the study
Active severe infection or malignancy
Known positive Hepatitis B antigen of Hepatitis C viral antibody
Known HIV antibodies
Received an investigational drug within 30 days of screening
Alcohol abuse within past 6 months
Hemochromatosis or other iron storage disorders
Significant cardiovascular disease
Any laboratory abnormality, medical condition or severe psychiatric disorder which in the opinion of the investigator woud put the subject's disease management at risk or may result in the subject being able to comply with the study requirements
Intervention: Acetylcysteine
Trial phase: Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
Eligibility criteria:
Inclusion Criteria:

men and women age 18-65;
current DSM-IV trichotillomania

Exclusion Criteria:

unstable medical illness;
history of seizures;
myocardial infarction within 6 months;
current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
any thoughts of suicide;
lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
previous treatment with N-Acetyl Cysteine;
treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline;
9) diagnosis of asthma
Intervention: Succinylcholine
Trial phase: Phase 4
ATC code: M03AB01
SMILES: C[N+](C)(C)CCOC(=O)CCC(=O)OCC[N+](C)(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 420
Group description: 1mg/kg
Eligibility criteria:
Inclusion Criteria:

indication for emergency intubation in intensive care
availability of qualified study physician

Exclusion Criteria:

contraindication against succinylcholine or rocuronium
indication for awake fibreoptic intubation
Intervention: Metoclopramide
Trial phase: Phase 2
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Metoclopramide group received standard care including IVF and also IV metoclopramide.
Eligibility criteria:
Inclusion Criteria:

Males or Females age 8-18 years
Girls 11 years or older must have a negative urine/serum pregnancy test.
Diagnosis of pediatric migrainous headache. The criteria for pediatric migraine headache based on the most recent ICHD criteria are listed below. The requirement of 5 attacks (A) will not be required for this study, this making the diagnosis migrainous headache. As described elsewhere in the protocol, this change is required to make the study applicable to ED patients who require treatment before five attacks have occurred.

Exclusion Criteria:

Evidence that headache is due to a secondary underlying disorder based on history or physical examination.
Pregnant or lactating females.
Any investigational drug use within 30 days.
Known to have a contraindication to metoclopramide or valproic acid such as pregnancy, liver disease, hematologic disease, or metabolic disease.
Have used metoclopramide (or other antidopaminergic medications) or valproic acid within two days of presentation.
Severe developmental disorders or mental retardation if insufficient information can be obtained to make a clear diagnosis of migraine or judge headache severity.
If patients re-present to the ED, they can not be re-enrolled.
Intervention: Rosuvastatin
Trial phase: Phase 3
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 42
Group description: rosuvastatin 5 mg
Eligibility criteria:
Inclusion Criteria:

Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)

Exclusion Criteria:

Certain medical conditions and lab test results
History of a reaction to rosuvastatin or other statin drugs
Use of specified disallowed medications
Intervention: Rosuvastatin
Trial phase: Phase 3
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 44
Group description: rosuvastatin 10 mg
Eligibility criteria:
Inclusion Criteria:

Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)

Exclusion Criteria:

Certain medical conditions and lab test results
History of a reaction to rosuvastatin or other statin drugs
Use of specified disallowed medications