AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT00870142
Drug: Norvasc® 10 mg Tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fasting conditions
Trial: NCT02232347
Drug: Sufentanil
RxNorm normalized name: Sufentanil
DrugBank: Sufentanil (DB00708)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01941095
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Participants may receive methotrexate as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.
Trial: NCT01456481
Drug: matching placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The target dose in this study is 10mg q4h x3 for 12 months. The starting dose is 5mg q4h x3, and if tolerated a forced titration up to 10mg/dose. If there is an intolerance, then the dose can be reduced to 2.5mg/dose.
Trial: NCT02196831
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: inactive substance that looks like tesamorelin
Trial: NCT02646163
Drug: REP 2055
FDA approved: no
EMA approved: no
PMDA approved: no
Description: (First two patients) REP 2055 is administered once weekly by slow IV infusion in dose escalation from 100 to 1200mg until a grade 3 adverse event is observed not to exceed 40 weeks of dosing.~(Subsequent patients) 400mg of REP 2055 is administered by slow IV infusion. First week of infusion to include daily dosing followed by twice weekly dosing for 40 weeks.
Trial: NCT00149643
Drug: Fluoxetine
RxNorm normalized name: Fluoxetine
DrugBank: Fluoxetine (DB00472)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Gelatin capsules Fluoxetine 10 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20 mg, 2 capsules barring side effects.
Trial: NCT01979900
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One vial of placebo diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well，once every 2 weeks, 6 times totally.
Trial: NCT03864978
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT02508389
Drug: Low Dose GC4419: 30mg/day
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Trial: NCT02508389
Drug: High Dose GC4419: 90mg/day
FDA approved: no
EMA approved: no
PMDA approved: no
Description: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Trial: NCT02508389
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Trial: NCT02933606
Drug: BNC210
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02933606
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03241875
Drug: Placebo oral capsule
RxNorm normalized name: Placebo Oral Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.
Trial: NCT02964975
Drug: Optimal medical therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Medical threatment according to guidelines
Trial: NCT01385033
Drug: [18F]MK-3328
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328
Trial: NCT04153604
Drug: doxycycline
RxNorm normalized name: Doxycycline
DrugBank: Doxycycline (DB00254)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: a tetracycline antibiotic that fights bacteria in the body.
Trial: NCT02906709
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo to omarigliptin orally once weekly
Trial: NCT01860976
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02715869
Drug: A pharmacologic cardiac preconditioning (Sevoflurane)
RxNorm normalized name: Leonurus cardiaca extract
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A Patients are anaesthetized by Sevoflurane more than 1 mac.
Trial: NCT03763175
Drug: SYN-010 21 mg
RxNorm normalized name: Gel-Syn
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 21 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels.
Trial: NCT03763175
Drug: SYN-010 42 mg
RxNorm normalized name: Gel-Syn
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 42 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels.
Trial: NCT03763175
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A placebo will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels.
Trial: NCT02392910
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: At each visit, the patient lay on a stretcher and underwent a vein cannulation in the forearm with a commercial canula no. 16, which was connected to IV tubing that was connected to a bag of isotonic saline solution 0.9% (200 ml). Each infusion was administered throughout 60 min. This scheme was followed for 5 consecutive weeks.
Trial: NCT00844519
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.
Trial: NCT00226655
Drug: hCRF [XERECEPT (corticorelin acetate injection)]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2mg/day
Trial: NCT02752477
Drug: Opioid-free general anesthetic
RxNorm normalized name: Gelato Anesthetic
FDA approved: no
EMA approved: no
PMDA approved: no
Description: An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions
Trial: NCT02752477
Drug: Traditional general anesthetic
RxNorm normalized name: Gelato Anesthetic
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil
Trial: NCT01568541
Drug: Regular toothpastes
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One tooth brushing
Trial: NCT01568541
Drug: Children's toothpastes
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One tooth brushing
Trial: NCT02178956
Drug: BBI608
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BBI608 480 mg orally two times daily (960 mg total daily dose)
Trial: NCT00434486
Drug: SKI-606
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03129646
Drug: Paromomycin
RxNorm normalized name: Paromomycin
DrugBank: Paromomycin (DB01421)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Paromomycin sulfate equiv to 750mg paromomycin / 2ml amp
Trial: NCT01759914
Drug: Superpotent topical steroid
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02802228
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: matched placebo delivered as infusion and oral capsule
Trial: NCT02863575
Drug: Ibuprofen/Caffeine
RxNorm normalized name: Ibuprofen/Caffeine/Vitamins B1, B2, B6, & B12 400 mg-65 mg-25 mg-6.25 mg-25 mg-125 mcg ORAL COMBINATION PACKAGE (EA)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ibuprofen/Caffeine fixed-dose combination
Trial: NCT02863575
Drug: Ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Ibuprofen capsule
Trial: NCT02863575
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo treatment
Trial: NCT02972398
Drug: placebo comparator of N-acetylcysteine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants of placebo group receive placebo comparator matching with N-acetylcysteine twice daily for 12 weeks.
Trial: NCT00006106
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00006106
Drug: ONYX-015
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00634972
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00720096
Drug: Liposomal Doxorubicin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Liposomal Doxorubicin 40 mg/m2 q 28 days
Trial: NCT03814343
Drug: 30% DMSO
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 30% DMSO was given to patients in placebo comparators group for continuous 12 weeks.
Trial: NCT02358681
Drug: Ketorolac, intranasal
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.
Trial: NCT02358681
Drug: Ketorolac, intravenous
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.
Trial: NCT02358681
Drug: Placebo, intravenous
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo of equal volume to IV ketorolac, to be administered by intravenous route.
Trial: NCT02358681
Drug: Placebo, intranasal
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo of equal volume to IN ketorolac, to be administered by intranasal route.
Trial: NCT00442936
Drug: Placebo to tecagepant 300 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo to match tecagepant 300 mg liquid-filled soft gel capsules
Trial: NCT00442936
Drug: Rescue medication
RxNorm normalized name: ALLERGENIC EXTRACT, MEADOW FESCUE POLLEN
FDA approved: no
EMA approved: no
PMDA approved: no
Description: If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.
Trial: NCT01223131
Drug: NPH insulin
RxNorm normalized name: NPH Insulin, Human 300 UNT per 3 ML Prefilled Syringe
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form:aqueous solution for injection~Route of administration: Subcutaneous
Trial: NCT01220206
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 placebo capsules daily
Trial: NCT01220206
Drug: One POMx capsule daily
RxNorm normalized name: Gel-One
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One POMx capsule, one placebo capsule daily
Trial: NCT00104689
Drug: capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01836705
Drug: SAR302503 (TG101348)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form:capsule~Route of administration: oral
Trial: NCT01836705
Drug: Placebo SAR302503
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form:capsule~Route of administration: oral
Trial: NCT01836705
Drug: Panolosetron
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form:solution~Route of administration: intravenous
Trial: NCT02048865
Drug: Placebo drug
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo drug 2.5mg BID for 6 months
Trial: NCT00746096
Drug: IKH-01
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ethinyl estradiol 0.035mg and norethisterone 1mg
Trial: NCT00746096
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
Trial: NCT04647604
Drug: Omegaven®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.
Trial: NCT03420482
Drug: Placebo oral capsule
RxNorm normalized name: Placebo Oral Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral placebo capsules filled with glycerol and cocoa powder. These capsules are identical in appearance to FMT capsules.
Trial: NCT04626635
Drug: Trifluridine-tipiracil
RxNorm normalized name: TRIFLURIDINE/TIPIRACIL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered per protocol
Trial: NCT00179400
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: This was a randomized placebo-controlled crossover study in which subjects received both agents in random order, separated by a wash-out period. Following 10 or 21 days' intervention, subjects underwent a pancreatic clamp study.
Trial: NCT03282838
Drug: Comparator Celebrex® (fed)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Comparator (Celebrex®) administered to fed subjects
Trial: NCT05722301
Drug: Testosterone Therapy
RxNorm normalized name: Testosterone
DrugBank: (1,2,6,7-3H)Testosterone (DB14093)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The testosterone pellet implantation will be performed 2 weeks before surgery. The dose is determined by baseline levels of sex hormone binding globulin (SHBG) in the following manner: If SHBG \> 60nmol/L implant 5 Testosterone Compounded 200mg (total 1000mgs testosterone). If SHBG 41-59 nmol/L implant 4 Testosterone Compounded 200mg (total 800mgs testosterone). If SHBG \<40 nmol/L implant 3 Testosterone Compounded 200mg (total 600mgs testosterone).
Trial: NCT00249860
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo will be administered subcutaneously three times a week for 12 weeks. The placebo responders will continue the study off-treatment after Week 12 up to Week 24
Trial: NCT02028754
Drug: Prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Prednisolone 1 drop in the study eye 4 times a day for the 1st week post surgery, 3 times a day for the 2nd week post surgery, 2 times a day for the 3rd week post surgery, and 1 time a day for the 4th week post surgery.
Trial: NCT01646307
Drug: Rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00731627
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: one tablet a day for up to 21 days
Trial: NCT00731627
Drug: simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: simvastatin 40mg once a day for a maximum of 21 days
Trial: NCT02586129
Drug: YH14755
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 20/1500mg, QD
Trial: NCT02586129
Drug: Rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 20mg, QD
Trial: NCT02210715
Drug: Isentress.
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 28 subjects will change from their normal cART treatment to Raltegravir, which will be given at the standard dose of 400 mg p.o. b.i.d. for 24 months.
Trial: NCT03943056
Drug: BIIB091
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered as specified in the treatment arm.
Trial: NCT03943056
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered as specified in the treatment arm.
Trial: NCT01768286
Drug: LDV/SOF
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
Trial: NCT00679666
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.
Trial: NCT01147523
Drug: Spironolactone/Vitamin E
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Spironolactone, tablets, 25 mg daily plus Vitamin E, capsules, 400 mg daily, for 52 weeks
Trial: NCT01611155
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT03319420
Drug: LO2A eye drops
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sodium hyaluronate
Trial: NCT03319420
Drug: Systane Ultra UD
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Active Ingredients; Polyethylene Glycol Propylene Glycol
Trial: NCT04572243
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo matching to lorcaserin oral tablet, administered as oral suspension.
Trial: NCT04456530
Drug: Aveed 750 MG in 3 ML IM Injection
RxNorm normalized name: testosterone
DrugBank: (1,2,6,7-3H)Testosterone (DB14093)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart.
Trial: NCT04321070
Drug: Clindamycin Phosphate
RxNorm normalized name: Clindamycin Phosphate
DrugBank: Clindamycin (DB01190)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: A thin film of investigation product will be applied to the affected areas of the face once daily
Trial: NCT04321070
Drug: Clindamycin Phosphate RLD
RxNorm normalized name: Clindamycin Phosphate
DrugBank: Clindamycin (DB01190)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: A thin film of investigation product will be applied to the affected areas of the face once daily
Trial: NCT04321070
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A thin film of investigation product will be applied to the affected areas of the face once daily
Trial: NCT02193425
Drug: F-18FDG
RxNorm normalized name: F
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 18F-Fluorodeoxyglucose (FDG)-PET session to assess the association between functional connectivity (FC) and glucose metabolism in the human brain.
Trial: NCT02359331
Drug: Tetracycline
RxNorm normalized name: Tetracycline
DrugBank: Tetracycline (DB00759)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02359331
Drug: 7 days tailored therapy Proton Pump Inhibitor
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03902912
Drug: Prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: prednisolone oral 10 mg/day from day one of the subsequent menstrual cycle to day LH 7 of that cycle. Then, the participants will be given a tailing off dose of 5 mg/day for 3 days followed by 2 mg/day for 3 days and then 1 mg/day for 3 days.
Trial: NCT01505530
Drug: LY2495655
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
Trial: NCT01505530
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
Trial: NCT01505530
Drug: Standard of Care Chemotherapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities).
Trial: NCT02063295
Drug: ZGN-440 for injectable suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03003338
Drug: OBV/PTV/r and DSV
FDA approved: no
EMA approved: no
PMDA approved: no
Description: OBV/PTV/r (12.5 mg/ 75 mg/ 50 mg) in combination with DSV (250 mg): Two tablets of OBV/PTV/r in the morning and one tablet of DSV in the morning and one tablet of DSV in the evening orally with a meal without regard to fat or calorie content.
Trial: NCT03003338
Drug: Placebo to match OBV/PTV/r and DSV
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo to match OBV/PTV/r and DSV
Trial: NCT01486433
Drug: Simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 40 mg (1 tablet) simvastatin once a day
Trial: NCT01486433
Drug: acetylsalicylic acid (ASA)
DrugBank: Acetylsalicylic acid (DB00945)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 81 mg aspirin (1 tablet), once a day, co-administered with simvastatin
Trial: NCT01486433
Drug: omefas
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 g (4 capsules) Epanova once a day, co-administered with simvastatin and aspirin