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NCT ID: NCT03152552 Terminated - Clinical trials for Diabetes Mellitus and Heart Failure

A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure

Start date: July 25, 2017
Phase: Phase 2
Study type: Interventional

This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure

NCT ID: NCT03131453 Terminated - Alzheimers Disease Clinical Trials

A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

GS2
Start date: August 3, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.

NCT ID: NCT03100409 Terminated - Radiation Toxicity Clinical Trials

Effect of a Low Residue Diet in Comparison to the Dietetic Recommendations From the INCan in Cervical Cancer Patients

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

In Mexico, cervical cancer (CC) ranks second in incidence and mortality among women. The National Institute of Cancer in Mexico (lNCan) receives annually about 500 patients with CC, 80% of which are diagnosed with locally advanced disease. The standard treatment for locally advanced disease consists in concomitant chemo-radiotherapy based on cisplatin (QT-RT), followed by brachytherapy, with an absolute benefit of 10%. Adverse effects include gastrointestinal toxicity, which is the most important factor limiting the dosage of pelvic radiation. Cancer treatment, in any modality, induces malnutrition, more so when combined treatments are administered. Radiation induced gastrointestinal toxicity is caused by different factors, among which are malabsorption of bile, fat and carbohydrates, decrease in brush border enzymes, diverticular disease, proctitis, and psychological factors. International guidelines for cancer patients recommend nutritional assessment in these patients before they start treatment, so nutritional risk can be detected and the patient may get started on dietary intervention to prevent malnutrition. Several authors have studied the dietary management that may help reduce the gastrointestinal effects in cancer patients receiving pelvic radiotherapy. To reduce diarrhea and prevent malnutrition the recommended dietary approach is a low residue diet consisting on 20-25% kcal from fat, 5g of lactose and 20g of fiber. Currently the INCan does not follow the nutrition care process for cervical cancer patients; written recommendations are given to the patients with a list of foods allowed or not allowed, with no further nutritional assessment or intervention. From previous studies, the investigators have demonstrated that the current recommendations do not help the patients maintain their nutritional status, during their treatment most patients become malnourished (81%, p<0.01). Therefore, the aim of this clinical trial is to evaluate a diet low in residue in CC patients, considering the necessary modifications for each patient if morbidities are present, in comparison with the current dietary recommendations used in the INCan.

NCT ID: NCT03071692 Terminated - Dyslipidemia Clinical Trials

Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

PROMINENT
Start date: March 23, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of: - nonfatal Myocardial Infarction (MI) - nonfatal ischemic stroke - coronary revascularization; or - Cardio Vascular (CV) death.

NCT ID: NCT03068754 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)

Start date: June 22, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

About 213 people with ALS will participate in this study. There will be locations in North and South America. During the first part, participants will be randomly assigned to a group (like by flipping a coin). Out of every 3: - 2 will get the study drug - 1 will get a look-alike with no drug in it (placebo) During the second part, everyone will get the study drug. Participation will help doctors find out if Acthar can help or slow down the symptoms of ALS better than placebo.

NCT ID: NCT03068130 Terminated - Clinical trials for Pulmonary Hypertension

Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER

RANGER
Start date: April 18, 2017
Phase: Phase 3
Study type: Interventional

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.

NCT ID: NCT03053063 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

STELLAR-4
Start date: January 30, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.

NCT ID: NCT03053050 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

STELLAR-3
Start date: February 13, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

NCT ID: NCT03052517 Terminated - Asthma Clinical Trials

Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

Start date: March 21, 2017
Phase: Phase 3
Study type: Interventional

This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: 1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and 2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.

NCT ID: NCT03033511 Terminated - Clinical trials for Small Cell Lung Cancer

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

MERU
Start date: February 7, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.