Consolidated Clinical Trials CCT

Closed Studies

TITLE OF STUDY

PHASE

INDICATION

STATUS

A Multicenter, 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

III

Type II Diabetes Mellitus

Closed

A 80-week extension to a mulitcenter, randomized, double-blind, active controlled study to compare the effect of 24 weeks treatment with LAF 237 50 mg bid to rosiglitazone 8 mg qd in drug naïve patients with type 2 diabetes

III

Type II Diabetes Mellitus

Closed

A multi-center, randomized, open-label, active controlled, parallel arm study to compare the efficacy of 12 weeks of treatment with Vildagliptin 100 mg, qd to thiazolidinedione (TZD) as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin in a community-based practice setting

III

Type II Diabetes Mellitus

Closed

A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS™ Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

IV

COPD

Closed

A randomized, parallel group, double-blind, multi-center study comparing the efficacy and safety of Avandament and Metformin after 80 weeks of treatment

III

Type II Diabetes Mellitus

Closed

A 12/6 month, double-dummy, randomized, parallel group, multicenter efficacy and safety study of SYMBICORT pMDI 2 x 160/4.5 mcg and 80/4/5 mcg bid compared to Formoterol TBH, Budesonide pMDI (and the combination) and placebo in COPD patients

III

COPD

Closed

A multi-site, cross-sectional, non-treatment, prospective trial to collect bio-fluids and neuropsychiatric data from cognitively normal elderly subjects

Method Trial

Psychiatric

Closed

A 26-week treatment, multicenter, randomized, double-blind, double dummy, 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 ug o.d.) in patients with chronic obstructive pulmonary disease using blinded formoterol (12 ug b.i.d) and open label tiotropium (18 ug o.d.) as active controls

II / III

COPD

Closed

Incidence of airway obstruction consistent with chronic obstructive pulmonary disease (COPD) in subjects with a history of cigarette smoking and symptoms of chronic bronchitis in a primary care setting

IV

COPD

Closed

A 28-week extension to a multicenter, double-blind, randomized, parallel-group study to compare the effect of 24 weeks treatment with LAF237 (50 mg qd or bid) to placebo as add-on therapy to pioglitazone 45 mg qd in patients with type 2 diabetes inadequately controlled with thiazolidinedione monotherapy

III

Type II Diabetes Mellitus

Closed

A Multicenter, 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

III

Type II Diabetes Mellitus

Closed

A 80-week extension to a mulitcenter, randomized, double-blind, active controlled study to compare the effect of 24 weeks treatment with LAF237 50 mg bid to rosiglitazone 8 mg qd in drug naïve patients with type 2 diabetes

III

Type II Diabetes Mellitus

Closed

L-TAP2: Lipid Treatment Assessment Project 2

Observational Survey

Dislipidemia

Closed

An 8-week randomized, double-blind, parallel group, multi-center, placebo and active controlled dose escalation study to evaluate the efficacy and safety of aliskiren (150 mg and 300mg) administered alone and in combination with valsartan (160 mg and 320 mg) in patients with hypertension

III

Hypertension

Closed

A 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group trial of lumiracoxib (COX189) 100 mg o.d. in patients with primary hip osteoarthritis using celecoxib (200 mg o.d.) as a positive control

III

Osteoarthritis (Hip)

Closed

A multi-center, randomized, double-blind, study to compare the effect of 24 weeks treatment with LAF 237 (50 mg qd, 50 mg bid or 100 mg qd) or placebo in drug naïve patients with type 2 diabetes

III

DMII

Closed

A multi-center, randomized, double-blind study to compare the effects of 24 weeks treatment with LAF 237 (50 mg qd, 50 mg bid or 100 mg qd) to placebo in drug naïve patients with type 2 diabetes

III

DMII

Closed

A 12-week, parallel-group, double blind, randomized, Placebo-controlled, multi-center, dose ranging study to Evaluate the efficacy, safety, and tolerability of GW823093 (2.5 mg, 7.5 mg, 15 mg, 30 mg, and 45 mg) administered orally, once daily, as monotherapy in subjects with type II Diabetes Mellitus

III

DMII

Closed

A 12 week, randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety of CEP-10953 (150 mg) as treatment for adults with excessive sleepiness associated with chronic shift work sleep disorder

III

SWSD

Closed

A 12 week randomized, double-blind, placebo- controlled, parallel group study to evaluate the safety and efficacy of CEP-10953 (150 mg/day) as treatment for adults with residual excessive sleepiness associated with obstructive sleep apnea/ Hypopnea syndrome

III

OSA

Closed

A 12 month, open label, flexible dosage (100 to 250 mg/day) extension study of the safety and efficacy of CEP-10953 in the treatment of patients with excessive sleepiness associated with narcolepsy obstructive sleep apnea/hypopnea syndrome or chronic shift work sleep disorder

III

OSA/SWSD

Closed

A randomized, double blind, placebo controlled parallel group study of the efficacy and multiple dose plasma concentration time profiles of Armodafinil (150, 200, and 250 mg) and Provigil (200 mg) in patients with chronic shift work sleep disorder

III

SWSD

Closed

A randomized, double-blind study to compare the durability of glucose lowering and preservation of pancreatic beta-cell function of Rosiglitazone Monotherapy compared to Metformin or Glyburide/ Glibenclamide in patients with drug-naïve, recently Diagnosed type 2 diabetes mellitus

IV

DMII

Closed

A 12 month, randomized, open label, multicenter, study to assess the long term safety of aliskiren 150 mg alone and 300 mg alone or with the optional addition of hydrochlorothiazide (12.5 mg or 25 mg) in patients with essential hypertension

IV

HTN

Closed

A 13-week, multi-center, 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

IV

Osteoarthritis

Closed

A multi-center, randomized, parallel-group study to compare the effect of 24 weeks treatment with LAF 237 (50 mg qd or bid) to placebo as add on therapy in patients with type 2 diabetes inadequately controlled with glimerpiride monotherapy

III

DMII

Closed

 
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