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Effect of simvastatin on myocardial triglyceride accumulation, cardiac function and al vessel wall thickness in patients with type 2 diabetes mellitus

To study the possible beneficial effect of simvastatin on accumulation of triglycerides in the myocardium of patients with DM2 and the effect on vessel wall thickness using magnetic resonance imaging and spectroscopy

A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma

This study has been transitioned to CTIS with ID 2022-500630-29-00 check the CTIS register for the current data. We hypothesise that treatment with nivolumab will extend disease-free survival, compared with placebo, as adjuvant therapy in all…

A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

This study has been transitioned to CTIS with ID 2024-511096-15-00 check the CTIS register for the current data. To assess the safety and tolerability of adjuvant treatment with olaparib

Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study
of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in
Men with Metastatic Castration-resistant Prostate Cancer.

This study has been transitioned to CTIS with ID 2024-511144-86-00 check the CTIS register for the current data. Primary objective: To determine the efficacy of the combination of olaparib and abiraterone vs placebo and abiraterone by assessment of…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

This study has been transitioned to CTIS with ID 2023-505696-74-00 check the CTIS register for the current data. The primary objective of this study is to demonstrate efficacy of BIIB059compared with placebo in participants with active systemic…

A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn*s disease with an option for open-label treatment extension (CALDOSE-2)

Primary objective• To determine the optimal dose of IMU-838 to induce symptomatic remission (based on stool frequency [SF] and abdominal pain [AP], as assessed in the Crohn*s Disease Activity Index [CDAI] patient reported outcome [PRO]-2) in…

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

This study has been transitioned to CTIS with ID 2022-501251-81-00 check the CTIS register for the current data. To compare disease free and overall survival of RCC patients, after adjuvant treatment with pembrolizumab after surgical renal resection…

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer

This study has been transitioned to CTIS with ID 2023-509360-24-00 check the CTIS register for the current data. Primary objectives: This study has co-primary objectives:• To compare OS of nivolumab versus placebo in subjects with resected EC or GEJ…

A randomised double-blind placebo-controlled clinical trial investigating the effect and
safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE plus)

This study has been transitioned to CTIS with ID 2023-506918-45-00 check the CTIS register for the current data. Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with…

A randomised double-blind placebo-controlled clinical trial investigating the effect and
safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE)

This study has been transitioned to CTIS with ID 2023-506919-18-00 check the CTIS register for the current data. Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with…

Shifting the interpretation bias and attention bias with an online training in borderline personality disorder

The purpose of the current study is to test the effectiveness of both trainings (IBT and ABT) in a non-clinical and clinical sample, with the future goal of making the training available to all patients with BPS. The central objectives for this…

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96 / ENGOT-ov65)

This study has been transitioned to CTIS with ID 2023-506177-35-00 check the CTIS register for the current data. Objective: To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab,…

A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab (TSR-042) plus Carboplatin-paclitaxel versus Placebo Plus Carboplatin-paclitaxel in Patients with Recurrent or Primary Advanced Endometrial Cancer (RUBY)

This study has been transitioned to CTIS with ID 2023-506551-23-00 check the CTIS register for the current data. This study has two parts. The purpose of the first part of the study is to investigate if the investigational drug called dostarlimab (…

A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis

This study has been transitioned to CTIS with ID 2023-506359-68-00 check the CTIS register for the current data. This study investigates the safety and efficacy of the new drug anifrolumab in patients with Lupus Nephritis. The effect of anifrolumab…

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson*s Disease

This study has been transitioned to CTIS with ID 2023-505645-12-00 check the CTIS register for the current data. Main objective: To evaluate the efficacy of BIIB122 225 mg compared with placebo.Secondary objective: To evaluate the efficacy, safety…

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer

This study has been transitioned to CTIS with ID 2023-506752-24-00 check the CTIS register for the current data. 1) Objective: To compare pembrolizumab plus chemotherapy to placebo plus chemotherapy with respect to PFS

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum-Based Chemotherapy with Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)

This study has been transitioned to CTIS with ID 2023-508443-40-00 check the CTIS register for the current data. Dual Primary Objectives:• To compare progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using…

A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Sickle Cell Disease

This study has been transitioned to CTIS with ID 2024-515202-84-00 check the CTIS register for the current data. Phase 2:Primary ObjectivesTo determine the recommended Phase3 dose of mitapivat by evaluating the effect of 2 dose levels of mitapivat…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients with Severe Hypertriglyceridemia

This study has been transitioned to CTIS with ID 2024-510696-38-00 check the CTIS register for the current data. Primary objective: To evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides from…

TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

This study has been transitioned to CTIS with ID 2024-510809-28-00 check the CTIS register for the current data. Primary objectiveTo demonstrate that talazoparib in combination with enzalutamide is superior to placebo in combination with…