Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) • Maintenance of healing of EE in adults. FDA label
Also known as Esomeprazole Magnesium, Esomeprazole, Esomeprazole Na, Rosuvastatin
Nexium · 47 trials · 35 indications
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase
CIMT measurements were made from ultrasound images of the common carotid artery (CCA), carotid bulb and internal carotid artery (ICA). The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. Twelve carotid artery sites were scanned at each visit and the 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for a specific segment. The annualized rate of change in the MeanMax CIMT measurements from each of the 12 sites, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.
Height z-score is a dimensionless quantity derived by subtracting the population mean from the individual raw score, and then deviding the difference by the pouulation SD of the reference population. This indicates how many SDs and observation is above or below the general population mean.
Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment
Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb \>20g/L (or Hct \>6%) during 24 hours or an increase in Hb \<10g/L (or Hct \<3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (\>200 ml) of fresh blood as estimated by the investigator.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.
Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as: \[sum(EEMcsa-LUMENcsa)/sum EEMcsa\]\*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.
Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value \* 100
To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)
To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)
To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)
To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks (PART B)
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 \[LOCF\] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 \[LOCF\] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
ln-transformed Cmax,ss of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
ln-transformed AUC0-tau of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
| Arm | Type | Description |
|---|---|---|
| Nexium - high dose | ACTIVE_COMPARATOR | Arm 1 (High dose = Healing dose) |
| Nexium - Low dose | ACTIVE_COMPARATOR | Arm 2 (Low dose = ½ healing dose) |
| Rosuvastatin | EXPERIMENTAL | 20 mg tablets, Daily oral dose |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablets |
| Single Arm | EXPERIMENTAL | One treatment period for all patients (\<1 year and 10 months), with the possibility to up-titrate dose to 40 mg of rosuvastatin for non-Asian patients. |
| Esomeprazole | EXPERIMENTAL | - |
| Cimetidine | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | Rosuvastatin 5mg qd |
| 2 | EXPERIMENTAL | Rosuvastatin 10mg qd |
| 3 | ACTIVE_COMPARATOR | Atorvastatin 10mg qd |
| Rosuvastatin 20 mg | EXPERIMENTAL | Rosuvastatin 20 mg distributed in 2-week run-in period |
| Atorvastatin 40 mg | ACTIVE_COMPARATOR | Atorvastatin 40 mg distributed in 2-week run-in period |
| Rosuvastatin 40 mg | EXPERIMENTAL | Rosuvastatin 40 mg distributed in core 2-year study |
| Atorvastatin 80 mg | ACTIVE_COMPARATOR | Atorvastatin 80 mg distributed in core 2-year study |
| rosuva 5 | ACTIVE_COMPARATOR | rosuvastatin 5 mg |
| rosuva 10 | ACTIVE_COMPARATOR | rosuvastatin 10 mg |
| rosuva 20 | ACTIVE_COMPARATOR | rosuvastatin 20 mg |
| rosuva ol | OTHER | rosuvastatin open label |
| Rosuvastatin 10mg | EXPERIMENTAL | - |
| 4 | ACTIVE_COMPARATOR | Simvastatin |
| AZD0780 +Rosuvastatin Dose 1 (Part A) | EXPERIMENTAL | * Participants will receive Rosuvastatin Dose 1 QD for minimum 21 days (up to 28 days) * Then receive AZD0780 QD as add on for next 28 days (Part A) |
| Placebo +Rosuvastatin Dose 1 (Part A) | PLACEBO_COMPARATOR | * Participants will receive Rosuvastatin Dose 1 QD for minimum 21 days (up to 28 days) * Then receive Placebo QD as add on for next 28 days (Part A) |
| AZD0780 +Rosuvastatin Dose 2 (Part A) | EXPERIMENTAL | * Participants will receive Rosuvastatin Dose 2 QD for minimum 21 days (up to 28 days) * Then receive AZD0780 QD as add on for next for 28 days (Part A) |
| Placebo + Rosuvastatin Dose 2 (Part A) | PLACEBO_COMPARATOR | * Participants will receive Rosuvastatin Dose 2 QD for minimum 21 days (up to 28 days) * Then receive Placebo QD as add on for 28 days (Part A) |
| AZD0780 (Part B Cohort 1) | EXPERIMENTAL | • Participate will receive AZD0780 QD for 52 weeks (Part B Cohort 1) |
| Placebo (Part B Cohort 1) | PLACEBO_COMPARATOR | • Participate will receive Placebo QD for 52 weeks (Part B Cohort 1) |
| AZD0780+Rosuvastatin Dose 1 (Part B Cohort 2) | EXPERIMENTAL | * Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive AZD0780 QD as add on for 12 weeks (Part B Cohort 2) |
| Placebo+Rosuvastation Dose 1 (Part B Cohort 2) | PLACEBO_COMPARATOR | * Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive Placebo QD as add on for 12 weeks (Part B Cohort 2) |
| Epanova® | EXPERIMENTAL | Multiple oral doses of 2 g (2 x 1 g capsules) Epanova® QD for 10 consecutive days (Days 4 to 13) |
| Epanova® + Crestor® | EXPERIMENTAL | Epanova® multiple oral doses of 4 g (4 x 1 g capsules) QD for 13 consecutive days (Days 14 to 26) with coadministration of single 40 mg (1 x 40 mg tablet) oral dose of rosuvastatin (Crestor®) with the 11th dose of 4 g Epanova® on Day 24 |
| Vascepa® | ACTIVE_COMPARATOR | Vascepa® multiple oral doses of 2 g (2 x 1 g capsules) every 12 hours for 20 consecutive days (Days 1 to 20). |
| Simvastatin | EXPERIMENTAL | Single, oral dose of simvastatin 40 mg in first period and in second period (after wash out) fostamatinib 100 mg twice daily, then single oral dose of simvastatin 40 mg plus continued oral dosing of fostamatinib 100 mg twice daily, then continue fostamatinib 100 mg twice daily |
| Name | Type | Description |
|---|---|---|
| Nexium 20mg | DRUG | Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks. |
| Nexium 10mg | DRUG | Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks. |
| Rosuvastatin | DRUG | 20mg tablets, orally once daily for the duration of the 104-week treatment period |
| Placebo | DRUG | Matching placebo tablets, orally once daily for the duration of the 104-week treatment period. |
| Rosuvastatin 20mg | DRUG | Active drug 1 or 2 tablets will be taken taken orally, QD, either in the morning or in the evening |
| Esomeprazole Na | DRUG | Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous |
| Cimetidine | DRUG | Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours |
| Esomeprazole Mg | DRUG | 40 mg tablet once daily for 27 days |
| Atorvastatin | DRUG | Capsule/Tablet, 10mg, oral, qd, 6 weeks |
| Rosuvastatin (Crestor) | DRUG | 10mg and 20 mg |
| Ezetimibe | DRUG | 10 mg |
| Simvastatin | DRUG | 40mg and 80 mg |
| pravastatin | DRUG | 40mg |
| Positron emission tomography | PROCEDURE | - |
| Esomeprazole magnesium (Nexium) | DRUG | - |
| aortic pulse wave velocity measurements | PROCEDURE | - |
| 10mg Rosuvastatin | DRUG | - |
| Maintenance of specific diet | BEHAVIORAL | - |
| Cholesterol lowering diet | BEHAVIORAL | - |
| Rosuvastatin Dose 1 | DRUG | Administered orally as tablets |
| Rosuvastatin dose 2 | DRUG | Administered orally as tablets |
| AZD0780 | DRUG | Administered orally as tablets |
| rosuvastatin 40 mg tablet | DRUG | Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1). |
| Epanova™ QD (2 x 1 g capsules) | DRUG | Multiple oral doses of 2 g (2 x 1 g capsules) Epanova™ QD for 10 consecutive days (Days 4 to 13) |
| Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose | DRUG | Multiple oral doses of 4 g Epanova™ QD for 13 consecutive days with coadministration of single 40 mg oral dose of rosuvastatin (Crestor®) with the 11th dose of Epanova™ on Day 24 |
| Multiple (20) oral doses of 2 g Vascepa® every 12 hours | DRUG | Multiple oral doses of 2 g (2 x 1 g capsules) Vascepa® every 12 hours for 20 consecutive days (Days 1 to 20). |
| Fostamatinib | DRUG | 100-mg tablet |
| esomeprazole magnesium | DRUG | capsules, oral, qd, one day |
Inclusion Criteria: 1. Patient must be 1 to 11 years of age 2. Patients must have a clinical history of GERD for at least 3 months before the start of study 3. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase...
Nexium is used for the treatment of erosive esophagitis, a condition in which acid reflux damages the lining of the esophagus. The clinical program for Nexium in erosive esophagitis includes a Phase 3 study evaluating maintenance of healing in pediatric patients from 1 to 11 years old.
Nexium is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the Phase 3 clinical program studying Nexium in erosive esophagitis, including the pediatric maintenance of healing trial conducted across multiple countries.
Nexium is in Phase 3 development for erosive esophagitis. The program includes one completed Phase 3 trial, and no trials are currently listed as active. The completed study was randomized, double blind, and active controlled, enrolling 53 patients.
Nexium has been studied in the Phase 3 trial NCT05267613, titled Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis. The trial is completed and enrolled 53 participants across the United States, Argentina, Australia, Belgium, Greece, Italy, Lithuania, Portugal, Spain, and Vietnam.
Nexium 20mg is used for erosive esophagitis, including maintenance of healing of the esophagus. The Phase 3 trial NCT05267613 evaluated oral Nexium in patients 1 to 11 years old with erosive esophagitis, assessing endoscopic evidence of maintained healing.