Clinical trials: Drug Use
Fertilization in Vitro
Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)
To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method.
- Trial name
- NCT00920361
- Testing
- Follitropin beta
- Volunteers
- 1,664 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Familial Hypercholesterolemia
Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan
The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.
- Trial name
- NCT02808403
- Testing
- No intervention
- Where
- 138 sites in Japan
- Volunteers
- 6,000 people
- Sponsor
- Amgen
Swine-Origin Influenza A H1N1 Virus
Drug Use Investigation for Cell-culture Derived Influenza A (H1N1) Emulsion HA Vaccine
This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects.
- Trial name
- NCT01098786
- Testing
- Cell-derived A/H1N1 influenza HA vaccine
- Where
- Japan
- Volunteers
- 556 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Type 2 Diabetes Mellitus
Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease"
The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.
- Trial name
- NCT04285983
- Testing
- Trelagliptin
- Where
- Japan
- Volunteers
- 89 people
- Sponsor
- Takeda
Macular Edema
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
The objectives of this study are to investigate the safety and effectiveness of EYLEA
- Trial name
- NCT02425501
- Testing
- Aflibercept (Eylea, BAY86-5321)
- Where
- Japan
- Volunteers
- 646 people
- Sponsor
- Bayer
Peripheral T Cell Lymphoma, Pediatric Hodgkin Lymphoma
Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"
The purpose of this survey is to examine the safety of adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with…
- Trial name
- NCT04213209
- Testing
- Brentuximab Vedotin (Genetical Recombination)
- Where
- Japan
- Volunteers
- 95 people
- Sponsor
- Takeda
Type 2 Diabetes
Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
The purpose of this study is to evaluate the safety and efficacy of long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients with type 2 diabetes mellitus who respond poorly to…
- Trial name
- NCT02098746
- Testing
- Pioglitazone/glimepiride
- Volunteers
- 294 people
- Sponsor
- Takeda
Diagnostic Imaging
Magnevist Post-marketing Surveillance in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Magnevist at a dose of more than 0.2 ml/kg for MR angiography of peripheral…
- Trial name
- NCT01376739
- Testing
- Gadopentetate dimeglumine (Magnevist, BAY86-4882)
- Where
- Japan
- Volunteers
- 2,051 people
- Sponsor
- Bayer
Epilepsy Intractable, Glucose Transporter Type 1 Deficiency Syndrome
Evaluation of Ketoflo
For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring a ketogenic diet will incorporate Ketoflo into their usual dietary regime.
- Conditions
- Epilepsy Intractable, Glucose Transporter Type 1 Deficiency Syndrome, Ketogenic Dieting
- Trial name
- Ketoflo (NCT04399954)
- Testing
- Ketoflo
- Where
- 5 sites in United Kingdom
- Volunteers
- 25 people
- Sponsor
- Vitaflo International, Ltd
Genital Herpes
Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)
The purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes.
- Trial name
- NCT01390805
- Testing
- Valaciclovir Hydrochloride.
- Volunteers
- 462 people
- Sponsor
- GlaxoSmithKline
Epilepsy
Special Drug Use Investigation for LAMICTAL® (Long Term)
The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (AED)…
- Trial name
- NCT01863602
- Testing
- Lamotrigine tablets
- Volunteers
- 850 people
- Sponsor
- GlaxoSmithKline
Surveillance
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and biguanides in participants with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet…
- Trial name
- NCT01964976
- Where
- Japan
- Volunteers
- 1,096 people
- Sponsor
- Takeda
Pulmonary Disease, Chronic Obstructive
Tiotropium in the Treatment of the Patients With Chronic Obstructive Pulmonary Disease
To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings
- Trial name
- COPD (NCT02177318)
- Testing
- Spiriva (tiotropium bromide) inhalation capsules
- Where
- 418 sites in Japan
- Volunteers
- 3,588 people
- Sponsor
- Boehringer Ingelheim
Drug Resistant Epilepsy, Ketogenic Dieting
Management of Drug-resistant Epilepsy in Infants and Children: a Real-life Study of the Use of the Ketogenic Diet in France and the KetoCal® Range in Its Maintenance
This is a multicenter, prospective, observational, longitudinal study designed to describe the therapeutic value of the KetoCal® range in the maintenance of a ketogenic diet during the management of infants (from 5 months) and…
- Trial name
- KEOPS (NCT06075485)
- Testing
- Ketocal
- Where
- France
- Volunteers
- 133 people
- Sponsor
- Nutricia Nutrition Clinique
Carcinoma, Renal Cell
Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC).
- Trial name
- NCT01411423
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- Japan
- Volunteers
- 3,305 people
- Sponsor
- Bayer
HIV-1 Infection
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this…
- Trial name
- NCT00823966
- Testing
- Rescriptor
- Volunteers
- 3 people
- Sponsor
- Pfizer
Type 2 Diabetes Mellitus
Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin…
- Trial name
- NCT01065766
- Testing
- Sitagliptin/metformin
- Volunteers
- 4,065 people
- Sponsor
- Merck Sharp & Dohme LLC
Respiratory Disorders
Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
The purpose of this post-marketing surveillance is to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and…
- Trial name
- NCT01395849
- Testing
- Salmeterol and Fluticasone
- Volunteers
- 2,116 people
- Sponsor
- GlaxoSmithKline
BiPolar
Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication
This study is to assess the pharmacokinetics of loxapine and will be using plasma concentration data obtained over 48 hours after administration of the study drug
- Trial name
- NCT02184767
- Testing
- ADASUVE®
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Social Phobia
Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)
The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.
- Trial name
- NCT01376271
- Testing
- Paroxetine
- Volunteers
- 600 people
- Sponsor
- GlaxoSmithKline