Previous Research

PrimeHealth has participated in over fifty clinical research trials (mostly Phase III) in several therapeutic areas within primary care.

The following is a chronological listing of our research trial experience over the past 15 years.

  • Chronic Kidney Disease (AstraZeneca – D5740C00001 – Oct 2015 – Ongoing)
    A phase III study evaluating the safety and efficacy for the treatment of anemia in chronic kidney disease patients not on dialysis.
  • Hyperlipidemia (CORTIA – PNAI-MNA-03 – Oct 2014 – Oct 2015)
    A phase II study to evaluate the regulating effects of investigational product on serum triglycerides and high-density lipoprotein cholesterol levels.
  • Overactive Bladder (Astellas-178-CL-102 – April 2014 – 2016)
    A phase III study to evaluate long-term safety and efficacy of combination of Solifenacin Succinate with Mirabegron compared to Solifenacin Succinate and Mirabegron monotherapy in subjects with overactive bladder.
  • Overactive Bladder (Astellas-178-CL-101 – Nov 2013 – 2016)
    A phase III study to evaluate long-term safety and efficacy of combination of Solifenacin Succinate with Mirabegron compared to Solifenacin Succinate and Mirabegron monotherapy in subjects with overactive bladder.
  • Nocturia (SERENITY – SER-DB4 – Oct 2013 to 2014)
  • Influenza (ROMARK – RM08-3002 – Jan 2014 to 2015)
    A phase III study to evaluate efficacy and safety of Nitazoxanide and Nitazoxanide plus Oseltamivir in the treatment of acute uncomplicated influenza.
  • Chronic Constipation (Ferring-000081 – Mar 2014 to 2015)
  • Chronic Constipation (Ferring-000079- Jul 2013 – 2015)
  • Chronic Constipation (Forest – LIN-MD-04 – Aug 2012 – 2014)
    A phase IIIb study to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating.
  • Viral Upper Respiratory (McNeil – ANPPWC2001- Oct 2011 – June 2012)
  • Diabetes (Novo Nordisk – NN9068-3951- Sep 2012 – Jan 2013)
    A phase IIIb study to evaluate the efficacy of insulin degludee/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapy.
  • Diabetes (JNJ – 2843175DIA3010 – Oct 2010 – 2013)
    A phase III study to evaluate the efficacy, safety, and tolerability of Canagliflozin compared with placebo in the treatment of older subjects with type 2 diabetes mellitus inadequately controlled on glucose lowering therapy.
  • Zoster (Shingles) (GSK- 022 – Sep 2010 – 2016)
    A phase III vaccination trial to assess the prophylactic efficacy, safety and immunogenicity of GSK vaccine when administered intramuscularly on a 0,2-month schedule in adults aged 70 years and older.
  • Zoster (Shingles) (GSK – 110390-006 – Sep 2010 – 2016)
    A phase III vaccination trial to assess the prophylactic efficacy, safety, and immunogenicity of GSK vaccine when administered intramuscularly on a 0,2-month schedule in adults aged 50 years and older.
  • Irritable Bowel Syndrome with Constipation (Forest –LIN-MD-02 – Dec 2009 to 2012)
    A phase III study to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).
  • Irritable Bowel Syndrome with Constipation (Forest – LIN-MD-31 – Aug 2009 to 2012)
    A phase III trial to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).
  • Chronic Constipation (Forest-LIN-MD-01 – 2009 to 2010)
    A phase III trial to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC).
  • Osteoarthrits (Knee or Hip) (Janssen-Ortho, 42160443PAI2004 – Jan 2010 to 2012)
    A phase II study to compare the safety and effectiveness of different doses of investigational product with placebo in the treatment of chronic, moderate to severe knee or hip pain in patients with a diagnosis of osteoarthritis.
  • Osteoarthrits (Low Back Pain) (Janssen-Ortho, 42160443PAI2003 – Jan 2010 to 2012)
    A phase II study to compare the safety and effectiveness of different doses of investigational product with placebo in the treatment of chronic, moderate to severe low back pain patients with a diagnosis of chronic low back pain.
  • Oral Contraception (Bayer, 13108 – Feb 2009 – Sep 2011)
    A phase III study to show superiority of the oral contraceptive investigational product over Ortho Tri-Cyclen Lo on hormone withdrawal-associated symptoms after 6 Cycles of treatment.
  • Perform (AstraZeneca; D3560L00090 – Mar 2009 – May 2009)
  • Osteoarthritis (Jannsen-Ortho; R333133-PAI-3020 – 2009 to 2009)
  • Migraine (GSK; MPX111381 – 2008 to 2010)
    A phase II study to evaluate dose response relationship, efficacy, safety and tolerability of target doses of investigational product compared to placebo in the prophylactic treatment of migraine headache.
  • Hot Flush (Wyeth; 3151A2-3353-NA – 2008 to 2010)
  • Diabetes (Combinator; CRx-401-001 – 2008 to 2009)
    A phase II trial to assess the safety and efficacy of investigational product in lowering FPG levels in patients taking metformin to treat their diabetes, as well evaluate insulin resistance (HOMA-IR index), HgbA1c levels, glycated protein, LDL, HDL, triglycerides, and total cholesterol.
  • Diabetes (Janssen-Ortho; 28431754-DIA-2001 – 2008 to 2008)
    A phase II study to evaluate the effectiveness, safety, and tolerability of investigational product compared with placebo in patients with type 2 diabetes.
  • Osteoarthritis (Pfizer; A3191172 PRECISION – 2008 to 2014)
    A phase IV study of cardiovascular safety in osteoarthritis or rheumatoid arthritis patients with or at high risk for cardiovascular disease comparing Celecoxib with Naproxen and Ibuprofen.
  • Cholesterol (Pharmanet; MK0653-112 – 2007 to 2008)
    A phase III trial of patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.
  • Vasomotor Study (Wyeth; DVS-405 – 2007 to 2008)
  • Osteoarthritis (Jannsen-Ortho; R333133-PAI-3010 – 2007 to 2008)
  • Osteoarthritis (Jannsen-Ortho; R333133-PAI-3008 – 2007 to 2008)
  • Osteoarthritis (Jannsen-Ortho; R333133-PAI-3002 – 2007)
  • Heavy Menstruation (Bayer; 309849-MIRENA – 2007 to 2008)
  • Dysfunctional Uterine Bleeding (Bayer; 308960-DUB – 2007 to 2008)
  • Hypercholesterolemia (AstraZeneca; JUPITER 4522US/0011 – 2006)
    A phase II study to determine the safety and effectiveness of long-term therapy with Rosuvastatin compared with a placebo, and to evaluate whether treatment with Rosuvastatin might be effective in reducing the risk of major cardiovascular events.
  • Depression (Lundbeck – Navigade; 99915 – 2005)
  • Osteoarthritis (GSK; CXA30007 – 2005)
    A phase III study to evaluate the effectiveness of investigational product in treating the signs and symptoms of osteoarthritis of the knee.
  • Hypertension / Dyslipidemia (Pfizer; Jewel A3841018 – 2005)
    A phase III study to evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.
  • Herpevac (GSK; 208141/039 (HSV 039) – 2004 to 2009)
    A phase III study to evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA.
  • Aspirin (AstraZeneca; Asterix D9617C00011 – 2004)
    A phase III study to evaluate the effect of esomeprazole 20 mg od versus placebo for the prevention of gastric and/or duodenal ulcers in patients taking low-dose ASA.
  • Diabetes (GSK; AXR100723 – 2004)
  • Intranasal Flu (PPD IDB; 13007 – 2003)
  • Diabetes (BMS; CV168-048 – 2003)
    A phase III study to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment is also studied.
  • Dyspepsia (AstraZeneca; DC QBE 0018 Enter Study – 2003)
  • Migraine (GSK; SUM 30047 – 2003)
  • Lipid Study (AstraZeneca; DISCOVER – 2002)
  • Migraine (GSK; SUM 40312 – 2003)
  • Migraine (GSK; S2W40028 – 2001)
  • Hypertension (GSK; AZA40052 – 2001)
  • Migraine (GSK; SUM 40291 – 2002)
  • Asthma (GSK; SAS 30024 – 2002)
  • Migraine (GSK; SUM 40285 – 2001)
  • Migraine (GSK; SUM 40291 – 2001)
  • Erectile Dysfunction (Pfizer; Prevalence of Erectile Dysfunction – 2001)
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