Clinical trials: in Venezuela
Anemia
LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
This single arm study will assess the efficacy and safety of Mircera when administered once monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia.
- Trial name
- NCT00517413
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 28 sites in Argentina, Brazil and 7 more
- Volunteers
- 163 people
- Sponsor
- Hoffmann-La Roche
Atrial Fibrillation
Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international…
- Trial name
- BOREALIS-AF (NCT00580216)
- Testing
- Idrabiotaparinux sodium, Warfarin, Avidin
- Where
- 538 sites in United States, Argentina and 46 more
- Volunteers
- 3,773 people
- Sponsor
- Sanofi
Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.
- Trial name
- NCT01110967
- Where
- 3 sites in Czechia, Slovakia and 1 more
- Volunteers
- 40 people
- Sponsor
- Medtronic Spinal and Biologics
Breast Cancer
CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)
This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs.
- Trial name
- CARIATIDE (NCT00681122)
- Where
- 164 sites in Australia, Austria and 16 more
- Volunteers
- 2,600 people
- Sponsor
- AstraZeneca
Chronic Myelogenous Leukemia
Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib
There is no available data on the clinical benefit of dose escalation for patients with suboptimal response to imatinib, and patients may still improve their response with continuation of therapy at the standard dose as shown in…
- Trial name
- LASOR (NCT00802841)
- Testing
- nilotinib, imatinib
- Where
- 56 sites in Argentina, Brazil and 10 more
- Volunteers
- 191 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Remitting Multiple Sclerosis (RRMS)
Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment
The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS).
- Trial name
- BEACON (NCT00787657)
- Testing
- Interferon beta-1b (Betaseron, BAY86-5046)
- Where
- 36 sites in Argentina, Bahrain and 34 more
- Volunteers
- 1,723 people
- Sponsor
- Bayer
Hepatitis C, Chronic
A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C
This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients…
- Trial name
- NCT01675427
- Testing
- Interleukin 28B testing
- Where
- 210 sites in United States, Argentina and 29 more
- Volunteers
- 4,766 people
- Sponsor
- Hoffmann-La Roche
Chronic Heart Failure
LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction
The study will assess the effects of 36 weeks of treatment with LCZ696 compared to valsartan on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart failure and preserved left-ventricular ejection…
- Trial name
- NCT00887588
- Testing
- LCZ696, Valsartan
- Where
- 81 sites in United States, Argentina and 12 more
- Volunteers
- 307 people
- Sponsor
- Novartis Pharmaceuticals
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
Rheumatoid Arthritis
A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active…
- Trial name
- NCT00754572
- Testing
- tocilizumab [RoActemra/Actemra], methotrexate
- Where
- 69 sites in Argentina, Brazil and 8 more
- Volunteers
- 418 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)
The aim of this retrospective study is to review and describe safety, tolerability and efficacy of Rebif® (subcutaneous interferon [IFN]-beta-1a) in children and adolescents, using information already recorded in medical records.
- Trial name
- REPLAY (NCT01207648)
- Testing
- Rebif®
- Where
- 18 sites in United States, Argentina and 6 more
- Volunteers
- 307 people
- Sponsor
- EMD Serono
Coronary Artery Stenosis, Coronary Arteriosclerosis
XIENCE V: SPIRIT WOMEN
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female…
- Conditions
- Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT00496938
- Testing
- XIENCE V®/ XIENCE PRIME™
- Where
- 95 sites in Argentina, Australia and 24 more
- Volunteers
- 1,600 people
- Sponsor
- Abbott Medical Devices
Cardiovascular Disease
Lipitor In The Prevention Of Stroke, For Patients Who Have Had A Previous Stroke
To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a previous stroke or transient ischemic attack.
- Trial name
- SPARCL (NCT00147602)
- Testing
- atorvastatin
- Where
- 130 sites in Australia, Austria and 23 more
- Volunteers
- 4,732 people
- Sponsor
- Pfizer
Non-Small Cell Lung Cancer
A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after…
- Trial name
- NCT00556322
- Testing
- Alimta or Taxotere, erlotinib [Tarceva]
- Where
- 123 sites in Australia, Austria and 25 more
- Volunteers
- 424 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer
A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease…
- Trial name
- NCT00556712
- Testing
- erlotinib [Tarceva]
- Where
- 133 sites in Australia, Austria and 26 more
- Volunteers
- 889 people
- Sponsor
- Hoffmann-La Roche
Blood Coagulation Disorders, Hemophilia A
Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with…
- Trial name
- NCT00969319
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 2 sites in Mexico, Venezuela
- Volunteers
- 105 people
- Sponsor
- Bayer
Chronic Kidney Disease Stage V, Hemodialysis
Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients
This study was designed to evaluate the effectiveness, safety, and impact on quality of life when paricalcitol (Zemplar® intravenous [IV]) is administered in Venezuelan patients on hemodialysis who are at risk of developing…
- Trial name
- NCT01758289
- Where
- 8 sites in Venezuela
- Volunteers
- 105 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Oral Contraceptive
Comparative Trial in Hormone Withdrawal Associated Symptoms
This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a…
- Trial name
- NCT01076582
- Testing
- EE20/DRSP (YAZ, BAY86-5300), Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)
- Where
- 44 sites in Argentina, Chile and 12 more
- Volunteers
- 592 people
- Sponsor
- Bayer
Lupus Nephritis
A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)] and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment for patients with lupus nephritis.
- Trial name
- NCT02081183
- Testing
- Mycophenolate mofetil (MMF), Cyclophosphamide, Maintenance Phase, Cyclophosphamide, Induction Phase
- Where
- 2 sites in Venezuela
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer
This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer.
- Trial name
- NCT00077025
- Testing
- Gefitinib, Anastrozole
- Where
- 27 sites in United States, Colombia and 2 more
- Volunteers
- 174 people
- Sponsor
- AstraZeneca