Clinical Trial Archive
The Dybedal Clinical Research Center has therapeutic experience in several disease states.
Select the disease state below to see past clinical trials.
AIDS/HIV
A long-term open-label rollover trial assessing the safety and tolerability of combination tipranavir and ritonavir use in HIV-1 infected subjects. (BIPI#1182.17) | Visit ClinicalTrials.gov
A multicenter, randomized, double-blind, placebo-controlled trial of a novel CCR5 antagonist, UK-427,857, in combination with optimized background therapy versus optimized background therapy alone for the treatment of antiretroviral-experienced HIV-1 infected subjects (Pfizer A4001028) | Visit ClinicalTrials.gov
A double-blind, placebo-controlled, dose-escalation study of the safety, tolerability, and pharmacokinetics of multiple oral doses of KP-1461 in HIV+ adults who have failed two or more highly active antiretroviral regimens (HAART). (Koronis KP-1461-102) | Visit ClinicalTrials.gov
Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir (APTIVUS/r) 500 mg/200 mg BID IN a racially and Gender diverse HIV-positive treatment experienced population with a pilot evaluation of therapeutic drug monitoring (TDM). (SPRING) 1182.98 | Visit ClinicalTrials.gov
Steady State Bioavailability of 2 different Viramune Extended Release formulations compared to steady state 400 mg of Viramune® (200 mg BID), in HIV infected subjects, an open label, non randomized, multidose and multistage parallel group study. (ERVIR) 1100.1489
Randomized, double-blind, parallel-group, placebo-controlled, two-stage study to assess the efficacy and safety of crofelemer 125mg, 250 mg, and 500 mg orally twice daily for the treatment of HIV-associated diarrhea (ADVENT Trial) NP303-101 | Visit ClinicalTrials.gov
An open-label, multicenter, mechanism validation study to evaluate the safety, efficacy, and tolerability of KP-1461 as monotherapy for 124 days in ARV-experienced, HIV-1 infected subjects. KP-1461-201 | Visit ClinicalTrials.gov
Utilization of HIV drug resistance testing in treatment experienced patients (UTILIZE study) 1182.116 | Visit ClinicalTrials.gov
A multicenter, randomized, double-blind, placebo-controlled trial of a novel CCR5 antagonist, UK-427,857, in combination with optimized background therapy versus optimized background therapy alone for the treatment of antiretroviral-experienced HIV-1 infected subjects (Pfizer A4001028) | Visit ClinicalTrials.gov
A double-blind, placebo-controlled, dose-escalation study of the safety, tolerability, and pharmacokinetics of multiple oral doses of KP-1461 in HIV+ adults who have failed two or more highly active antiretroviral regimens (HAART). (Koronis KP-1461-102) | Visit ClinicalTrials.gov
Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir (APTIVUS/r) 500 mg/200 mg BID IN a racially and Gender diverse HIV-positive treatment experienced population with a pilot evaluation of therapeutic drug monitoring (TDM). (SPRING) 1182.98 | Visit ClinicalTrials.gov
Steady State Bioavailability of 2 different Viramune Extended Release formulations compared to steady state 400 mg of Viramune® (200 mg BID), in HIV infected subjects, an open label, non randomized, multidose and multistage parallel group study. (ERVIR) 1100.1489
Randomized, double-blind, parallel-group, placebo-controlled, two-stage study to assess the efficacy and safety of crofelemer 125mg, 250 mg, and 500 mg orally twice daily for the treatment of HIV-associated diarrhea (ADVENT Trial) NP303-101 | Visit ClinicalTrials.gov
An open-label, multicenter, mechanism validation study to evaluate the safety, efficacy, and tolerability of KP-1461 as monotherapy for 124 days in ARV-experienced, HIV-1 infected subjects. KP-1461-201 | Visit ClinicalTrials.gov
Utilization of HIV drug resistance testing in treatment experienced patients (UTILIZE study) 1182.116 | Visit ClinicalTrials.gov
Asthma
A 52-week, randomised, double-blind, parallel-group, multicentre, Phase IIIB study comparing the long term safety of SYMBICORT pMDl 160 /4.5 micrograms X 2 actuations twice daily budesonide HFA pMDl 160 mg x 2 actuations twice daily in adult and adolescent (> 12 years) African American subjects with asthma" ("Multi-Center Study") (Astrazeneca D5896C00022) | Visit ClinicalTrials.gov
A two-week, randomised, double-blind study assessing the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose in adult subjects (> 18 years of age) with mild to moderate asthma, receiving SYMBICORT" pMDl 80mg x 2 actuations twice daily or budesonide HFA pMDl 80 mg x 2 actuations hvice daily" (Astrazeneca D5896C00025) | Visit ClinicalTrials.gov
A two-week, randomised, double-blind study assessing the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose in adult subjects (> 18 years of age) with mild to moderate asthma, receiving SYMBICORT" pMDl 80mg x 2 actuations twice daily or budesonide HFA pMDl 80 mg x 2 actuations hvice daily" (Astrazeneca D5896C00025) | Visit ClinicalTrials.gov
Allergies, Seasonal
Not Listed
Cholesterol
Not Listed
Chronic Back Pain
A six week double-blind, randomized, multicenter comparison study of the analgesic effectiveness of celecoxib 200 mg BID compared to tramadol hydrochloride 50 mg QID in subjects with chronic low back pain. (Pfizer A3191165) | Visit ClinicalTrials.gov
Chronic Bronchitis
Outcomes of patients not responding to outpatient macrolide or B-lactam therapy for the treatment of acute exacerbations of chronic bronchitis caused by streptococcus pneumoniae (HMR3647A/6012) | Visit ClinicalTrials.gov
Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT) | Visit ClinicalTrials.gov
Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT) | Visit ClinicalTrials.gov
COPD
Effect of roflumilast on exacerbation rate in patients with chronic obstructive pulmonary disease. Altana - BY217/M2-111 | Visit ClinicalTrials.gov
Effect of ROFUMILAST on exacerbation rate in patients with COPD. A 52 week, double-blind study with 500µg ROFUMILAST once daily versus placebo. (Altana BY217/M-125) | Visit ClinicalTrials.gov
A phase IIIB, 12-month, double-blind, double-dummy, randomised, parallel-group, multicentre exacerbation study of SYMBICORT® pMDI 160/4.5 µg x 2 actuations twice-daily and 80/4.5 µg x 2 actuations twice-daily compared to formoterol TBH 4.5 µg x 2 inhalations twice-daily in COPD subjects (D589CC00003) | Visit ClinicalTrials.gov
A 25-week treatment, multicenter, randomized, double-blind, placebo-controlled, adaptive, seamless, parallel-group study to assess the efficacy, safety and tolerability of two doses of indacaterol (selected from 75, 150, 300 & 600 µg o.d.) in patients with chronic obstructive pulmonary disease using blinded formoterol (12 µg b.i.d.) and open label tiotropium (18 µg o.d.) as active controls (CQAB149B2335S) | Visit ClinicalTrials.gov
Efficacy and safety of inhaled human insulin (exubera) compared with subcutaneous human insulin in the therapy of adult subjects with type 1 or type 2 diabetes mellitus and chronic obstructive pulmonary disease: a one-year, multicenter, randomized, outpatient, open-label, parallel-group comparative trial. (A2171030) | Visit ClinicalTrials.gov
Effect of ROFUMILAST on exacerbation rate in patients with COPD. A 52 week, double-blind study with 500µg ROFUMILAST once daily versus placebo. (Altana BY217/M-125) | Visit ClinicalTrials.gov
A phase IIIB, 12-month, double-blind, double-dummy, randomised, parallel-group, multicentre exacerbation study of SYMBICORT® pMDI 160/4.5 µg x 2 actuations twice-daily and 80/4.5 µg x 2 actuations twice-daily compared to formoterol TBH 4.5 µg x 2 inhalations twice-daily in COPD subjects (D589CC00003) | Visit ClinicalTrials.gov
A 25-week treatment, multicenter, randomized, double-blind, placebo-controlled, adaptive, seamless, parallel-group study to assess the efficacy, safety and tolerability of two doses of indacaterol (selected from 75, 150, 300 & 600 µg o.d.) in patients with chronic obstructive pulmonary disease using blinded formoterol (12 µg b.i.d.) and open label tiotropium (18 µg o.d.) as active controls (CQAB149B2335S) | Visit ClinicalTrials.gov
Efficacy and safety of inhaled human insulin (exubera) compared with subcutaneous human insulin in the therapy of adult subjects with type 1 or type 2 diabetes mellitus and chronic obstructive pulmonary disease: a one-year, multicenter, randomized, outpatient, open-label, parallel-group comparative trial. (A2171030) | Visit ClinicalTrials.gov
Diabetes
Efficacy and safety of inhaled human insulin (exubera) compared with subcutaneous human insulin in the therapy of adult subjects with type 1 or type 2 diabetes mellitus and chronic obstructive pulmonary disease: a one-year, multicenter, randomized, outpatient, open-label, parallel-group comparative trial. (A2171030) | Visit ClinicalTrials.gov
A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of Saxagliptin (BMS-477118) in combination with metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone (BMS CV181014) | Visit ClinicalTrials.gov
A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of saxagliptin (BMS-477118) as monotherapy in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise. (BMS CV181011) | Visit ClinicalTrials.gov
A multicenter, randomized, double-blind, placebo-controlled phase 3 trial to evaluate the efficacy and safety of saxagliptin (BMS-477118) in combination with glyburide in subjects with type 2 diabetes who have inadequate glycemic control on glyburide alone. (BMS CV181040) | Visit ClinicalTrials.gov
A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of SAXAGLIPTIN (BMS-477118) as monotherapy with titration in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise. (BMS CV181038) | Visit ClinicalTrials.gov
A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of Saxagliptin (BMS-477118) in combination with metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone (BMS CV181014) | Visit ClinicalTrials.gov
A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of saxagliptin (BMS-477118) as monotherapy in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise. (BMS CV181011) | Visit ClinicalTrials.gov
A multicenter, randomized, double-blind, placebo-controlled phase 3 trial to evaluate the efficacy and safety of saxagliptin (BMS-477118) in combination with glyburide in subjects with type 2 diabetes who have inadequate glycemic control on glyburide alone. (BMS CV181040) | Visit ClinicalTrials.gov
A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of SAXAGLIPTIN (BMS-477118) as monotherapy with titration in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise. (BMS CV181038) | Visit ClinicalTrials.gov
Emphysema
Not Listed
Fibromyalgia
A 12-week, open-label, safety trial of pregabalin in patients with fibromyalgia. (Pfizer A0081078) | Visit ClinicalTrials.gov
A 13-week, randomized, double-blind, placebo-controlled trial of pregabalin twice daily in patients with fibromyalgia. (Pfizer A0081077) | Visit ClinicalTrials.gov
An 8-week, randomized, double-blind, placebo-controlled, multi-centre study of REBOXETINE ([S, S]-Reboxetine, PNU-165442G) administered once daily in patients with fibromyalgia. (Pfizer A6061034) | Visit ClinicalTrials.gov
A 13-week, randomized, double-blind, placebo-controlled trial of pregabalin twice daily in patients with fibromyalgia. (Pfizer A0081077) | Visit ClinicalTrials.gov
An 8-week, randomized, double-blind, placebo-controlled, multi-centre study of REBOXETINE ([S, S]-Reboxetine, PNU-165442G) administered once daily in patients with fibromyalgia. (Pfizer A6061034) | Visit ClinicalTrials.gov
Gastro-esophageal Reflux
Not Listed
High Cholesterol
Not Listed
Hypertension (High Blood Pressure)
A randomized, double-blind, placebo-controlled, forced-titration, Phase IV study comparing telmisartan 80 mg + hydrochlorothiazide 25 mg versus valsartan 160 mg + hydrochlorothiazide 25 mg taken orally for 8 weeks in patients with Stage 1 or Stage 2 hypertension (BIPI 502.476) | Visit ClinicalTrials.gov
A randomized, double-blind, double-dummy, placebo-controlled, 4x4 factorial design trial to evaluate telmisartan 20, 40 and 80 mg tablets in combination with amlodipine 2.5, 5 and 10 mg capsules after eight weeks of treatment in patients with Stage I or II hypertension, with an ABPM sub-study. (BIPI 1235.1) | Visit ClinicalTrials.gov
A double-blind, randomized, placebo-and active-controlled, forced titration study evaluating the effects of NEBIVOLOL on blood pressure and heart rate in African American patients with hypertension. (Mylan-Bertek NEB 310) | Visit ClinicalTrials.gov
An open-label, randomized study evaluating the long-term effects of metoprolol versus nebivolol as monotherapy or in combination with amlodipine or hydrochlorothiazide for the treatment of patients with hypertension (NEB-324) Visit ClinicalTrials.gov
A randomized, double-blind, double-dummy, placebo-controlled, 4x4 factorial design trial to evaluate telmisartan 20, 40 and 80 mg tablets in combination with amlodipine 2.5, 5 and 10 mg capsules after eight weeks of treatment in patients with Stage I or II hypertension, with an ABPM sub-study. (BIPI 1235.1) | Visit ClinicalTrials.gov
A double-blind, randomized, placebo-and active-controlled, forced titration study evaluating the effects of NEBIVOLOL on blood pressure and heart rate in African American patients with hypertension. (Mylan-Bertek NEB 310) | Visit ClinicalTrials.gov
An open-label, randomized study evaluating the long-term effects of metoprolol versus nebivolol as monotherapy or in combination with amlodipine or hydrochlorothiazide for the treatment of patients with hypertension (NEB-324) Visit ClinicalTrials.gov
Infectious Disease
Not Listed
Influenza
Not Listed
Irritable Bowel Syndrome
Not Listed
Pregnancy
Not Listed
Reactive Airway Disorder
Not Listed