Clinical trials: Pharmacovigilance
Hemophilia A
Study Evaluating Refacto For Pharmacovigilance
The purpose of this study is to investigate the effectiveness and safety of treatment with ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment will be done.
- Trial name
- NCT00195442
- Testing
- Moroctocog alfa
- Where
- 26 sites in Austria, Germany
- Volunteers
- 288 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Epilepsy, Partial
Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the…
- Trial name
- NCT00643500
- Testing
- Levetiracetam
- Volunteers
- 342 people
- Sponsor
- UCB Pharma
Benign Prostatic Hyperplasia
Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1).
- Trial name
- NCT00593593
- Volunteers
- 1,000 people
- Sponsor
- GlaxoSmithKline
Von Willebrand Disease
A Canadian Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced)
As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective, multi-center structured data collection of routine…
- Trial name
- NCT00701545
- Where
- Canada
- Volunteers
- 21 people
- Sponsor
- CSL Behring
Early Breast Cancer
Electronic Study for Anastrozole Pharmacovigilance Evaluation
Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer
- Trial name
- E-SAFE (NCT00558168)
- Volunteers
- 1,850 people
- Sponsor
- AstraZeneca
Adverse Drug Reactions
A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review.
- Trial name
- NCT01354730
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Adimmune Corporation
Safety Issues
Direct Acting Anti-Viral's In Chronic HCV Patients
The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated…
- Trial name
- NCT04664894
- Testing
- Sofosbuvir
- Where
- Pakistan
- Volunteers
- 511 people
- Sponsor
- Getz Pharma
Hypertension
Pharmacovigilance and Patient Compliance in Hypertensive Patients
Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan.
- Trial name
- NCT02200575
- Testing
- Telmisartan
- Volunteers
- 10,333 people
- Sponsor
- Boehringer Ingelheim
Pulmonary Disease, Chronic Obstructive
Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Primary objective: Evaluation of the safety of Seretide discus administration in subjects with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1), treatment phase (visits 2-5.
- Trial name
- NCT00662805
- Testing
- Salmeterol/Fluticasone propionate
- Volunteers
- 762 people
- Sponsor
- GlaxoSmithKline
Melanoma
Ipilimumab 12-month Intensive Pharmacovigilance Protocol
The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period
- Trial name
- NCT02050594
- Testing
- Ipilimumab
- Where
- Venezuela
- Volunteers
- 6 people
- Sponsor
- Bristol-Myers Squibb
Hemophilia B
Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.
- Trial name
- NCT00714415
- Testing
- BeneFIX
- Where
- 21 sites in Austria, Germany
- Volunteers
- 80 people
- Sponsor
- Pfizer
Tuberculosis
Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program
Phase IV, observational, cohort, prospective study. With duration according to the indicated scheme, 6 months of treatment (2 intensive months and 4 months of sotén) for pulmonary tuberculosis.
- Trial name
- NCT04916899
- Testing
- Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
- Where
- Mexico
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
Advanced Melanoma, Hepatitis B
Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C…
- Conditions
- Advanced Melanoma, Hepatitis B, Hepatitis C
- Trial name
- Yervoy RMP (NCT02402699)
- Where
- Taiwan
- Volunteers
- 3 people
- Sponsor
- Bristol-Myers Squibb
Hunter Syndrome
Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)
The purpose of this non-interventional, observational study which is conducted in Mexico is to evaluate the safety profile of elaprase (idulsurfase) in participants with hunter syndrome (mucopolysaccharydosis II) being treated…
- Trial name
- NCT03582449
- Where
- 6 sites in Mexico
- Volunteers
- 5 people
- Sponsor
- Shire
Epilepsy
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug.
- Trial name
- NCT00631150
- Testing
- Levetiracetam (Keppra)
- Volunteers
- 35 people
- Sponsor
- UCB Pharma
Buprenorphine, Naloxone
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic…
- Conditions
- Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence
- Trial name
- OPUS R (NCT00723697)
- Testing
- buprenorphine
- Volunteers
- 1,307 people
- Sponsor
- Indivior Inc.
Intra-Abdominal Infections, Skin Disease, Infectious
Post-Authorization Study Evaluating Safety Of Tigecycline
This is a study to evaluate the safety of tigecycline in patients with complicated intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI) under real practice in the usual hospital setting and…
- Conditions
- Intra-Abdominal Infections, Skin Disease, Infectious, Soft Tissues Infections
- Trial name
- HORUS (NCT00827541)
- Testing
- Tigecycline
- Volunteers
- 115 people
- Sponsor
- Pfizer
Infection
A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily…
- Trial name
- NCT00488488
- Testing
- tigecycline
- Volunteers
- 1,028 people
- Sponsor
- Pfizer
Bipolar Disorder, Schizophrenia
A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy)…
- Trial name
- NCT01053429
- Testing
- ziprasidone
- Volunteers
- 3,391 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hemophilia A
Study Evaluating Pharmacovigilance Of Refacto AF
The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
- Trial name
- NCT00895037
- Testing
- ReFacto AF (Moroctocog alfa)
- Where
- 24 sites in Austria, Germany
- Volunteers
- 101 people
- Sponsor
- Pfizer