Clinical trials: Treatment Adverse Effect
- Condition Treatment Adverse Effect
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Carcinoid Syndrome
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
- Trial name
- TELEPATH (NCT02026063)
- Testing
- Telotristat etiprate
- Where
- 43 sites in United States, Australia and 10 more
- Volunteers
- 124 people
- Sponsor
- Lexicon Pharmaceuticals
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction
- Trial name
- CLEAR Serenity (NCT02988115)
- Testing
- bempedoic acid
- Where
- 67 sites in United States, Canada
- Volunteers
- 345 people
- Sponsor
- Esperion Therapeutics, Inc.
Asthma, Aspirin-Induced
Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD).
- Trial name
- NCT03028350
- Testing
- Ifetroban Oral Capsule
- Where
- 16 sites in United States
- Volunteers
- 54 people
- Sponsor
- Cumberland Pharmaceuticals
Carcinoid Syndrome, Carcinoid
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome.
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum
- Trial name
- NCT05361668
- Testing
- Randomized: 40 mg Paltusotine, Randomized: 80 mg Paltusotine
- Where
- 35 sites in United States, Argentina and 5 more
- Volunteers
- 36 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Epilepsy
Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)
Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and…
- Trial name
- NCT01653262
- Testing
- Brivaracetam
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 29 people
- Sponsor
- UCB Pharma SA
Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use
Food and Insulin Effect on QT/QTC Interval of ECG
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or…
- Conditions
- Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State
- Trial name
- C11035 (NCT01642485)
- Testing
- Moxifloxacin 400 mg fasted, FDA breakfast, Continental breakfast
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Richmond Pharmacology Limited
Diabetes Mellitus, Type 2, Coronary Artery Disease
Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
The purpose of this study is to determine whether bromodomain extraterminal domain (BET) inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major…
- Trial name
- BETonMACE (NCT02586155)
- Testing
- Apabetalone, Atorvastatin, Rosuvastatin
- Where
- 214 sites in Argentina, Australia and 13 more
- Volunteers
- 2,425 people
- Sponsor
- Resverlogix Corp
Anemia, Iron-Deficiency, Kidney Failure, Chronic
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents…
- Trial name
- NCT00224042
- Testing
- Sodium Ferric Gluconate complex in sucrose, Ferrous sulfate tablets
- Where
- 24 sites in United States, Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Watson Pharmaceuticals
Carcinoid Syndrome
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week…
- Trial name
- NCT01677910
- Testing
- Telotristat etiprate
- Where
- 75 sites in United States, Australia and 10 more
- Volunteers
- 135 people
- Sponsor
- Lexicon Pharmaceuticals
Renal Transplant
Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation
This open, multi-center randomized controlled study is designed to investigate the quality of life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse events after converting to enteric-coated…
- Trial name
- NCT00239005
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS), Mycophenolate Mofetil (MMF)
- Where
- United Kingdom
- Volunteers
- 134 people
- Sponsor
- Novartis Pharmaceuticals
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with…
- Trial name
- GAUSS-3 (NCT01984424)
- Testing
- Atorvastatin, Ezetimibe
- Where
- 58 sites in United States, Australia and 11 more
- Volunteers
- 511 people
- Sponsor
- Amgen
Renal Cell Carcinoma
To Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving Axitinib in for the Treatment of Advanced Renal Cell Carcinoma
To assess how dose reductions or treatment interruptions related to axitinib can be implemented to manage and resolve adverse events occurring among patients with advanced renal cell carcinoma treated with first-line axitinib in…
- Trial name
- NCT04682587
- Testing
- Axitinib, Avelumab, Pembrolizumab
- Where
- United States
- Volunteers
- 481 people
- Sponsor
- Pfizer
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Primary Immunodeficiency Diseases (PID)
A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16…
- Trial name
- NCT05755035
- Testing
- TAK-881, HYQVIA
- Where
- 32 sites in United States, Czechia and 6 more
- Volunteers
- 65 people
- Sponsor
- Takeda
Hypogonadism, Cardiovascular Diseases
A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.
- Trial name
- TRAVERSE (NCT03518034)
- Testing
- AndroGel®
- Where
- 384 sites in United States, Puerto Rico
- Volunteers
- 5,246 people
- Sponsor
- AbbVie
Glioblastoma Multiforme
UNITE Study: Understanding New Interventions With GBM ThErapy
The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor…
- Trial name
- NCT03419403
- Testing
- Steroid eye drops, Vasoconstrictor eye drops, Cold compress
- Where
- 22 sites in United States, Australia and 3 more
- Volunteers
- 40 people
- Sponsor
- AbbVie
Melanoma
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)
Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year.
- Trial name
- NCT00723710
- Testing
- Intron A (interferon alfa-2b; SCH 30500)
- Volunteers
- 299 people
- Sponsor
- Merck Sharp & Dohme LLC
Akathisia, Drug-Induced, Dyskinesia, Drug-Induced
Study of Preladenant for the Treatment of Antipsychotic Induced Movement Disorders in Participants With Schizophrenia (Study P04628)
This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder.
- Conditions
- Akathisia, Drug-Induced, Dyskinesia, Drug-Induced, Parkinsonian Disorders
- Trial name
- NCT00686699
- Testing
- Preladenant
- Volunteers
- 11 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV
Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and…
- Trial name
- NCT00460746
- Testing
- TMC125, Darunavir; Ritonavir
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Tibotec, Inc
Hypercholesterolemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in…
- Trial name
- GAUSS-4 (NCT02634580)
- Testing
- Evolocumab, Ezetimibe
- Where
- 35 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Amgen