Clinical trials: Impairment
Healthy Volunteers, Renal Impairment
Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001)
The purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of MK-6183 (CB-238,618) in humans.
- Trial name
- NCT02341599
- Testing
- MK-6183
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Alzheimer Disease, Mild Cognitive Impairment
Evaluation of Web-based Training to Educate Physicians in the Methods of Interpreting Florbetapir-PET Scans
This study will investigate the performance of physician readers trained to read florbetapir-PET scans using electronic media training.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Neurodegenerative Diseases
- Trial name
- NCT01550549
- Testing
- florbetapir F 18
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Alzheimer Disease
Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease and impaired glucose tolerance.
- Trial name
- Elevage (NCT03980730)
- Testing
- Azeliragon
- Where
- 33 sites in United States, Canada
- Volunteers
- 43 people
- Sponsor
- vTv Therapeutics
Renal Function Impairment in Healthy Volunteers
Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on renal function and perfusion in 16 healthy subjects.
- Trial name
- NCT02992236
- Testing
- VAS203, Saline
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- veriNOS operations GmbH
Diabetes Mellitus, Type 2, Kidney Function Tests
The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function.
The purpose of this study is to evaluate how dapagliflozin mechanism of action is impacted by Type 2 Diabetes Mellitus status and kidney function
- Trial name
- DAPASALT (NCT03152084)
- Testing
- Dapagliflozin
- Where
- 4 sites in Netherlands, Sweden
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Mild Cognitive Impairment, Alzheimer Disease
Safety and Immunogenicity of Repeated Doses of ABvac40 in Patients With a-MCI or Vm-AD
Alzheimer's disease (AD) is the most common type of dementia, accounting for 50-75% of the estimated 47 million people with dementia worldwide.
- Trial name
- NCT03461276
- Testing
- ABvac40
- Where
- 23 sites in France, Italy and 2 more
- Volunteers
- 134 people
- Sponsor
- Araclon Biotech S.L.
Renal Impairment
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.
- Trial name
- NCT01740362
- Testing
- CP-690,550
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Impairment
Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed…
- Trial name
- NCT04678505
- Testing
- MK-3402
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Alzheimer Disease, Cognitive Impairment
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best therapeutic dose of sodium…
- Trial name
- NCT01453569
- Testing
- Sodium oligo-mannurarate 600mg, Sodium oligo-mannurarate 900mg
- Where
- 24 sites in China
- Volunteers
- 255 people
- Sponsor
- Shanghai Greenvalley Pharmaceutical Co., Ltd.
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4
A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic…
- Trial name
- SOTA-CKD4 (NCT03242018)
- Testing
- Sotagliflozin
- Where
- 106 sites in United States, Argentina and 13 more
- Volunteers
- 277 people
- Sponsor
- Lexicon Pharmaceuticals
Mild Cognitive Impairment, Dementia
A 3 Year Study to Evaluate the Safety and Efficacy of Low Dose Ladostigil in Patients With Mild Cognitive Impairment
The purpose of this study is to determine whether treatment with the investigational drug ladostigil will delay the onset of Alzheimer's disease(AD) in patients with Mild Cognitive Impairment (MCI).
- Trial name
- NCT01429623
- Testing
- ladostigil hemitartrate
- Where
- 12 sites in Austria, Germany and 1 more
- Volunteers
- 210 people
- Sponsor
- Avraham Pharmaceuticals Ltd
Sensorineural Hearing Loss
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
- Trial name
- NCT04462198
- Testing
- PIPE-505
- Where
- 8 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Contineum Therapeutics
Persistent Allergic Asthma
Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood…
- Trial name
- NCT00870584
- Testing
- Omalizumab
- Where
- 50 sites in United States
- Volunteers
- 271 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Kidney Disease (CKD)
Study of the Safety, Tolerability, and Pharmacokinetics of LHW090 in Patients With Moderately Impaired Renal Function
This was a randomized, double-blind, parallel group, placebo-controlled study, in two sequential parts that evaluated the renal safety, tolerability and pharmacokinetics of LHW090 in patients with moderately impaired renal…
- Trial name
- LHW090 (NCT02678000)
- Testing
- LHW090
- Where
- 12 sites in United States, Germany
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
Communication Disorders
Adaptive and Individualized AAC
This project will test the feasibility of developing a smart augmentative or alternative communication (AAC) system that is effective in delivering communication capabilities that automatically adapt to the users' physical…
- Trial name
- NCT04247828
- Testing
- Experimental AAC, Generic AAC
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Altec Inc.
Migraine
Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function
This is a multi-center, open-label, non-randomized, parallel-group, adaptive, single dose study. This study will enroll up to 32 participants using an adaptive design that can include up to 3 groups of 8 participants with…
- Trial name
- NCT03009162
- Testing
- Lasmiditan
- Where
- 2 sites in Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.
- Trial name
- NCT02683577
- Testing
- telotristat etiprate
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ipsen
Chronic Hepatitis B
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic…
- Trial name
- NCT03180619
- Testing
- TAF
- Where
- 30 sites in United States, Canada and 6 more
- Volunteers
- 124 people
- Sponsor
- Gilead Sciences
Schizophrenia
A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.
- Trial name
- NCT02953639
- Testing
- Basmisanil
- Where
- 37 sites in United States
- Volunteers
- 214 people
- Sponsor
- Hoffmann-La Roche
Acute Heart Failure
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared…
- Trial name
- NCT02002702
- Testing
- Serelaxin
- Where
- 15 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals