What We’ve Done

Clinical publications:

  1.  A randomized, double blind, comparative trial of Micafungin (FK463) vs Fluconazole in the treatment of Oesophageal Candidiasis (Alim Pharmacol Ther 2005; 21:899-907)
  2.  A randomized, double blind trial of Anidulafungin vs Fluconazole in the treatment of Oesophageal Candidiasis (Clinical Infectious Diseases 2004; 39:770-775)
  3.  A Randomized, Double-Blind, Comparative Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Oesophageal Candidiasis (Alimentary Pharmacology and Therapeutics 24 March 2005; 21:889-907) https://onlinelibrary.wiley.com/doi/10.1111/j.1365-2036.2005.02427.x
  4.  Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with long acting bronchodilators: two randomised clinical trials.  Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Lancet. 2009 Aug 29;374(9691):695-703. doi: 10.1016/S0140-6736(09)61252-6.  (Corroborator)
  5.  Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1. Erratum in: Lancet. 2010 Oct 2;376(9747):1146. (Corroborator)

Clinical experience:

I participated in a number of clinical trials which enhanced my clinical ability:

  1. Comparison of the efficacy and safety in patients with Asthma of Ipratropium bromide 40 mcg and 80 mcg formulated in a lactose base powder inhaled and delivered by the FO2 device, with the currently approved Atrovent metered dose inhaler.
  2. A prospective, randomised, open-label blinded endpoint trial comparing Telmisartan (Micardis®) 80 mg and Losartan 50 mg + Hydrochlorothiazide5 mg (Lozaar plus®, Hyzaar®) in patients with mild-to-moderate essential Hypertension using ambulatory blood pressure monitoring.
  3. A multicentre, open-label study of the efficacy and safety of Oral HMR 3647 800mg once daily for 10 days in adult subjects with Community-Acquired Pneumonia.
  4. Linezolid versus Vancomycin in the treatment of patients with Nosocomial Pneumonia.
  5. A randomised, 24-week, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of Ariflo (15 mg twice daily) in patients with Chronic Obstructive Pulmonary Disease (COPD).
  6. A multidose comparison of Tiotropium inhalation capsules, Salmeterol inhalation  aerosol and placebo in a six-month, double-blind, double-dummy, safety and efficacy study in patients with Chronic Obstructive Pulmonary Disease (COPD)
  7. A single-mind, multicentre, randomised, group comparative, 12-week study to demonstrate the safety of Sodium Cromoglycate 5mg HFA-227 MDI versus Intal/Lomudal 5mg (5 mg / 10 mg QID) in 3600 adult, adolescent and paediatric Asthmatic
  8. A multicentre, open-label extension study to evaluate the safety, tolerability and efficacy of oral SB 207499 (15mg twice daily) in patients with Chronic Obstructive Pulmonary Disease (COPD).
  9. Linezolid (PNU-100766) given intravenously or orally for use in patients with significant, multi-drug Resistant Gram-positive Infections, or in patients unsuitable to standard therapy.
  10. A double-blind, active-controlled study of the efficacy and safety of Oral HMR 3647 (800mg once daily) 5 days versus 7 days versus 10 days oral Clarithromycin (500mg twice daily) in the treatment of Community-Acquired Pneumonia.
  11. A prospective, randomised, double-blind, double-dummy, titration-to-response trial comparing MICARDIS® (telmisartan) (40 or 80 mg p.o. once daily) and COZAAR® / LOZAAR® (losartan) (50 or 100 mg p.o. once daily) in patients with mild-to-moderate Hypertension using ambulatory blood pressure monitoring.
  12. A twelve-week, efficacy and safety study comparing Respimat® Budesonide (100 and 200 μg, 2 puffs bid) with Turbohaler® Budesonide (200 μg, 2 puffs bid) in symptomatic adult moderate to severe Asthmatics requiring inhaled corticosteroids and bronchodilator therapy.
  13. A Phase III randomised, double-blind, double-dummy, non-inferiority study of the safety and efficacy of intravenous anidulafungin (VER004-2) Vs oral fluconazole in the treatment of patients with Oesophageal Candidiasis.
  14. A randomised, double-blind, phase III, comparative study of Cedecin (Daptomycin) to Rocephin (Ceftriaxone) in the treatment of moderate to severe Community-Acquired Acute Bacterial Pneumonia due to Streptococcus pneumoniae.
  15. Efficacy and safety of Symbicort® (budesonide/formoterol) Turbohaler® as single therapy in patients with mild-moderate asthma. Comparison with conventional Asthma therapy, Pulmicort® (budesonide) Turbohaler® as maintenance treatment complemented with Bricanyl® (terbutaline) Turbohaler®.
  16. A prospective, randomised, blinded, parallel group study of Clotrimazole troches vs. Mycelex® troches in patients with Human Immunodeficiency Virus (HIV) Infection for the treatment of Oropharyngeal Candidiasis.
  17. A multinational, multi-centre, prospective, double-blind, parallel group, randomised study of faropenem daloxate (BAY 56-6854) oral tablets compared to clarithromycin oral tablets, in the treatment of Acute Exacerbation of Chronic Bronchitis.
  18. Prophylaxis of Venous Thromboembolism in patients with acute medical conditions requiring prolonged immobilization: a comparison of Daltaparin (Fragmin®) 5000IU vs Placebo in a double-blind, randomized, multicentre study.
  19. Efficacy and safety of Symbicort® (budesonide/formoterol) Turbohaler® as single therapy in patients with moderate-severe Asthma. Comparison with conventional asthma therapy, Pulmicort® (budesonide) Turbohaler® as maintenance treatment complemented with Bricanyl® (terbutaline) Turbohaler®.
  20. Prospective, non-comparative, open-label, multi-centre, multi-national trial to evaluate the safety and effectiveness of Moxifloxacin oral tablets, 400mg once daily for 10 days in the treatment of patients with drug resistant Community Acquired Pneumonia.
  21. A 4 day, double-blind, placebo-controlled, multicentre study of IV YM087 (Conivaptan) (CI – 1025) to assess efficacy and safety in patients with euvolemic or hypervolemic Hyponatremia.
  22. An international, multi-centre, stratified, randomised, double- blind, double-dummy, parallel-group, 52-week gastrointestinal clinical safety study to demonstrate that COX189 (400 mg od) reduces the risk to develop complicated ulcers as compared to NSAIDs (naproxen 500 mg bid and ibuprofen 800 mg tid), in Osteoarthritis.
  23. A 52 week multi-centre, randomised, double- blind, double-dummy, placebo controlled parallel group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination (Seretide/Viani/Advair) 50/100mcg once daily in the morning with fluticasone propionate 100mcg twice daily and placebo (SABA only) twice daily, all via the Diskus/Accuhaler as initial maintenance therapy in mild Asthmatic
  24. A clinical study to investigate the effects of treatment with Tegaserod in patients with constipation-predominant Irritable Bowel Syndrome.
  25. A 13-week, multicentre, randomized, double-blind, double-dummy, placebo-controlled, parallel trial of 2 different dose regimens of Lumiracoxib (100 mg od and 200 mg od initial dose for two weeks followed by 100 mg od) in patients with primary Knee Osteoarthritis, using celecoxib (200 mg od) as a comparator.
  26. A Phase 3, randomized, double-blind, comparative trial of Micafungin (FK463) versus fluconazole in the treatment of Oesophageal Candidiasis.
  27. A multinational, randomized, double-blind, placebo-controlled, forced titration, 2 X 2 factorial design study of the efficacy and safety of long-term administration of Nateglinide and Valsartan in the prevention of diabetes and cardiovascular outcomes in subjects with Impaired Glucose Tolerance.
  28. A randomised, double-blind, double-dummy, placebo- and active controlled, parallel-group efficacy and safety comparison of 12-week treatment of two doses [5μg (2 actuations of 2.5 μg) and 10 μg (2 actuations of 5 μg)] of Tiotropium inhalation solution delivered by Respimat inhaler, placebo and Ipratropium Bromide inhalation aerosol (MDI) in patients with Chronic Obstructive Pulmonary Disease (COPD).
  29. A multi-centre, randomized, double-blind, parallel group, active-controlled, 24-weeks study to evaluate the efficacy of the combination Valsartan/hydrochlorothiazide versus Amlodipine on systolic blood pressure in patients with moderate Hypertension with additional cardiovascular risk factors or concomitant conditions.
  30. A randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GW685698X 100ug administered once-daily either in the morning or the evening and compared with GW685698X administered 250ug once daily in the evening all delivered by inhaled via Diskhaler/Diskus for 28 days in patients with Mild to Moderate Persistent Bronchial Asthma.
  31. Change of health-related quality of life (HR-Qol) in patients suffering from endoscopically confirmed Reflux Esophagitis after treatment with Pantoprazole 40mg o.d. over 4 weeks.
  32. A Phase I study of the safety and pharmacokinetics of repeated-dose Micafungin (FK463) in adults (≤ 16 years) with Oesophageal candidiasis.
  33. A Randomized, Double-Blind, Placebo-, Active-Controlled, Parallel Group Study to Determine Safety and Efficacy of Oral SD-6010 (iNOS) in treating
  34. A 24 Week, Multi-Centre, Controlled, Open-labelled, Parallel, Randomised Efficacy and Safety Comparison of NovoMix® 30 Once daily with Metformin vs NovoMix® 30 Monotherapy Twice Daily in Subjects with Type 2 Diabetes.
  35. A 13-week, double-blind, active controlled extension to CCOX189A2361, a 13-week multicentre, randomized, double-blind, double-dummy, placebo-controlled, parallel trial of 2 different dose regimens of Lumiracoxib (100 mg od and 200 mg od initial dose for two weeks followed by 100 mg od) in patients with Primary Knee Osteoarthritis, using celecoxib (200 mg od) as a comparator.
  36. A Phase 3, Randomized, Double Blind, Comparative Trial of Two Dosing Regimens of Micafungin (FK463) versus Caspofungin for the Treatment of Oesophageal Candidiasis
  37. A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study comparing Ciclesonide (160 ug in the evening) and fluticasone/salmeterol (100 ug/50 ug bid) versus placebo in patients with Mild Bronchial Asthma.  (ECCO)
  38. Comparison of efficacy of Symbicort Turbohaler 160/4.5 ug b.i.d. plus as needed, Seretide pMDI 50/250ug b.i.d. plus Bricanyl as needed, and Symbicort Turbohaler 320/9ug b.i.d. plus Bricanyl as needed in adult and adolescent Asthma A randomised, Double-Blind, Parallel-Group, phase IIIB study. (COMPASS)
  39. A 24-Week, Double-Blind, Parallel Group, Placebo- and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast taken with Low Dose Inhaled Corticosteroids in Patients with Chronic Asthma.
  40. A Phase II, randomized, multicentre, double-blind study to investigate the efficacy and safety of three dosing regimens of water-soluble azole (WSA) BAL 8557 compared to fluconazole in the treatment of patients with uncomplicated Oesophageal Candidiasis (EC)
  41. A double-blind, randomized, multi-centre, active controlled, parallel-group study comparing the combination of Valsartan 320mg plus hydrochlorothiazide 12.5mg and valsartan 320mg plus hydrochlorothiazide 25mg to valsartan 320mg in mild to moderate Hypertensive patients not adequately controlled with valsartan 320mg.
  42. Effect of Roflumilast on exacerbation rate in patients with Chronic Obstructive Pulmonary A 52-weeks double-blind study with 500ug Roflumilast once daily versus placebo. (OPUS)
  43. A six-week, randomized, double-blind, parallel-group, multicentre study to evaluate the safety and efficacy of the combination of Aliskiren 150mg and amlodipien 5mg compared to amlodipien 5mg and 10mg in Hypertensive patients not adequately responsive to amlodipien 5mg.
  44. A Phase 3, multi centre, double-blind, randomised, parallel group study of efficacy, safety, and tolerability of fixed combination Torcetrapib (CP-529,414/Atorvastatin) administered orally, once daily (QD) for six months, compared with maximally tolerated Atorvastatin therapy alone, in subjects with Heterozygous Familial Hypercholesterolemia.
  45. A Phase 3, multi centre, open label, forced titration study to evaluate the efficacy, safety, and tolerability CP-529,414/Atorvastatin combination administered orally, once daily in patients with Homozygous Familial Hypercholesterolemia (HOFH)
  46. Comparison of the efficacy and safety of Symbicort® Turbohaler® 160/4.5ug bid plus as needed with Seretide™ Diskus™ 50/500ug bid plus Terbutaline Turbohaler® 0.4mg as needed – a 6-month randomised, double-blind, parallel-group, active controlled, multinational, phase IIIB study in adult and adolescent patients with
  47. A randomised, double blind, placebo controlled, parallel group study to assess the effect of the endothelin receptor antagonist Avosentan on time to doubling of serum creatinine, end stage renal disease or death in patients with Type 2 Diabetes Mellitus and Diabetic Nephropathy.
  48. A Multicentre, Double-blind, Randomized, Active Controlled Study to Compare the effect of 52 Weeks Treatment with Vildagliptin 50 mg bid to Pioglitazone 30 mg Daily as add-On Therapy in Patients with Type 2 Diabetes Inadequately Controlled with Metformin monotherapy
  49. A Two-year, Multinational, Multi-Centre, 2:1 Randomised, Parallel-group, Open-labelled trial comparing the Efficacy and Safety of Insulin Detemir and NPH Insulin in Subjects with Type 1 Diabetes on a basal-bolus regimen with Insulin apart as mealtime Insulin.
  50. A Phase 3, Multi-Centre, Open Label Safety Study of RSD1235 in Subjects with Atrial Fibrillation
  51. Reduction of vascular inflammation and coronary atherosclerosis with AGI-1067, a V- Protectant, reduces cardiovascular events in patients with Coronary Artery Disease. (ARISE)
  52. A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg QD and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis.
  53. A double-blind, randomised, placebo-controlled study to investigate chronic intermittent “pulse” therapy of Moxifloxacin as a prevention of acute exacerbation in out-patients with Chronic Bronchitis.
  54. A placebo-controlled, double-blind, randomized study to evaluate the efficacy and safety of TAK-475 50 mg and 100 mg versus placebo, when co-administered with simvastatin 20 mg or 40 mg in subjects with primary Dyslipidaemia.
  55. A placebo-controlled, double-blind, randomized study to evaluate the efficacy and safety of TAK-475 100 mg in subjects with Type 2 Diabetes currently treated with lipid-lowering therapy.
  56. Conformation of superiority of complete remission concept vs classical healing concept for treatment of patients with erosive GERD (CONFIRM)
  57. Effect of Roflumilast in COPD patients treated with salmeterol. A 12-week, double blind study with 500 mcg roflumilast once daily versus placebo. (EOS)
  58. A randomised, double-blind, placebo-controlled phase III survival study with Rosuvastatin in subjects with Chronic Symptomatic Systolic Heart Failure.
  59. Effect of Roflumilast on exacerbation rate in patients with A 52 weeks, double- bind study with 500 mcg roflumilast once daily versus placebo. (HERMES)
  60. A Phase II, Multicenter, Randomized, Double-Mask, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects with Uncomplicated Acute Influenza.
  61. A double-blind, placebo-controlled, randomized, parallel-group study evaluating the efficacy and tolerability of oral 115959, a novel A2A agonist, versus placebo in the treatment of diabetic neuropathic pain.
  62. A Multicentre, Double-blind, Randomized, forced-titration study to compare the efficacy  and safety of the combination of 145mg Fenofibrate and 20 or 40 mg Simvastatin with 40 mg Pravastatin monotherapy in patients with mixed dyslipidaemia at risk of cardiovascular disease not adequately controlled by 40 mg Pravastatin alone. (FOURNIER)
  63. Double-blind, randomized, parallel-group, dose ranging, multi-centre study to evaluate the efficacy and safety of 2.5, 10, 35 and 50 mg AVE7688 once daily, using 100 mg losartan potassium once daily as calibrator, for 12 months treatment, in patients with mild to moderate Hypertension (RAVEL)
  64. A 52-week randomized, double-blind, parallel group, placebo controlled, multicentre clinical trial, to assess the efficacy and safety of 200µg of the anti-cholinergic LAS 34273 compared to placebo, both administered once-daily by inhalation, in the maintenance treatment of patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (ALMIRAL)
  65. An international, multicentre, randomized, double-blind, double-dummy, parallel group, study of 3-month or 6-month treatment with SSR126517E / Idraparinux (3.0 mg s.c. once weekly) versus oral INR-adjusted warfarin in the treatment of patients with symptomatic Pulmonary Embolism, with or  without symptomatic deep venous thrombosis (CASSIOPEA)
  66. A double-blind, placebo-controlled efficacy (as assessed by post-bronchodilator FEV1) and safety study of 5mg Ro3300074 (Palovarotene) once-daily for up to two years in subjects with smoking-related moderate-to-severe COPD with emphysema receiving concurrent optimal emphysema drug therapy, with assessment of disease-modifying effect. (BREATHE)
  67. A Phase II, Multicentre, Randomized, Double-Mask, Double-Dummy Study Comparing the Efficacy and Safety of Peramivir Administered Intravenously Once Daily versus Oseltamivir Administered Orally Twice Daily in Adults with Acute Serious or Potentially Life-Threatening Influenza.
  68. A Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600mg PO, BID For 5 Days Versus Placebo in The Treatment of Acute Exacerbation of Chronic Bronchitis
  69. A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel ArmStudy to Evaluate Efficacy and Safety ofApixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation (ARISTOTLE)
  70. Direct Factor Xa inhibitor YM150 Apixaban for Prevention of Stroke in Subjects with Non-Valvular Atrial Fibrillation. A double blind, parallel, dose-finding study in comparison with open label warfarin.
  71. A Phase 3 Randomised, Double-blind, Parallel-group, Multi-centre Study of the Safety and Efficacy of Apixaban for the Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalisation. (ADOPT)
  72. A Phase 2b Dose-Ranging Study of PAC-113 Mouth rinse for Clinical and Microbial Evaluation in HIV Seropositive Individuals with Oral Candidiasis to Establish the Optimal Dose of PAC-113
  73. A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel group study to evaluate the efficacy and safety of Once-daily orally administered PH-797804 (0.5, 3,6 and10mg) in Adults with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
  74. A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-group, Multicentre, Dose-ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 250cmg Twice daily compared with Placebo for 8 weeks in Adolescent and  Adult Subjects with Persistent Asthma Symptomatic on Low-dose Inhaled Corticosteroid Therapy.