Publication of clinical trial results
The information given below and the relevant links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO). They supplement the information published in association with the Swiss marketing authorisation for the medicinal product.
Swiss marketing authorization number: 67583
Date of Swiss marketing authorization: 14.12.2020
Initial Marketing Authorization:
Study 1002-047
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk (CLEAR Wisdom)
- EudraCT Number: 2016-003486-26
- Clinical Trials gov ID: NCT02991118
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT02991118
Study 1002-040
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
- EudraCT Number: 2015-004136-36
- Clinical Trials gov ID: NCT02666664
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT02666664
Indication extension:
Study 1002-043
- Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo (CLEAR Outcomes)
- Clinical Trials gov ID: NCT02993406
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT02993406
Study 1002-046
- Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant (CLEAR Serenity)
- Clinical Trials gov ID: NCT02988115
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT02988115
Study 1002-048
- Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
- Clinical Trials gov ID: NCT03001076
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03001076
Swiss marketing authorization number: 67586
Date of Swiss marketing authorization: 15.12.2020
Initial Marketing Authorization:
Study 1002FDC-053
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
- Clinical Trials gov ID: NCT03337308
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03337308
Indication extension:
Study 1002-043
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo (CLEAR Outcomes)
- Clinical Trials gov ID: NCT02993406
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT02993406
Study 1002-048
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
- Clinical Trials gov ID: NCT03001076
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03001076
Swiss marketing authorization number: 67967
Date of Swiss marketing authorization: 29.11.2021
Initial Marketing Authorization:
DS8201-A-U201 / DESTINY-Breast01
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
- EudraCT Number: 2016-004986-18
- Clinical Trials gov ID: NCT03248492
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03248492
Indication extension:
DS8201-A-U301 / DESTINY-Breast02
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
- EudraCT Number: 2018-000221-31
- Clinical Trials gov ID: NCT03523585
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03523585
DS8201-A-U303 / DESTINY-Breast04
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
- EudraCT Number: 2018-003069-33
- Clinical Trials gov ID: NCT03734029
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03734029
DESTINY-Breast06
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer (DB-06)
- EudraCT Number: 2019-004493-26
- Clinical Trials gov ID: NCT04494425
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT04494425
DS8201-A-U205 / DESTINY-Gastric02
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
- EudraCT Number: 2019-001512-34
- Clinical Trials gov ID: NCT04014075
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT04014075
DS8201-A-J202 / DESTINY-Gastric01
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
- Clinical Trials gov ID: NCT03329690
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03329690
DPT02 / DESTINY-PanTumor02
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02)
- EudraCT Number: 2020-001574-29
- Clinical Trials gov ID: NCT04482309
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT04482309
DS8201-A-U204 /DESTINY-Lung01
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer (DESTINY-Lung01)
- EudraCT Number: 2017-004781-94
- Clinical Trials gov ID: NCT03505710
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03505710
DS8201-A-U207 / DESTINY-CRC02
Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02)
- EudraCT Number: 2020-004782-39
- Clinical Trials gov ID: NCT04744831
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT04744831
Swiss marketing authorization number: 69710
Date of Swiss marketing authorization: 31.03.2025
Initial Marketing Authorization:
AC220-A-U302
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) (QuANTUM-First)
- EudraCT Number: 2015-004856-24
- Clinical Trials gov ID: NCT02668653
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT02668653
Swiss marketing authorization number: 69801
Date of Swiss marketing authorization: 28.05.2025
Initial Marketing Authorization:
TROPION-Breast01
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
- EudraCT Number: 2020-005620-12
- Clinical Trials gov ID: NCT05104866
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05104866
MED-CH-BEMP-00017
