Consolidated Clinical Trials CCT

Closed Studies

TITLE OF STUDY

PHASE

INDICATION

STATUS

A multicenter, randomized, double-mask, placebo-controlled, parallel study to investigate the efficacy and safety of 20 mg Tasimelteon versus placebo on totally blind subjects with N24HSWD followed by an ole phase

III

Sleep Disorder

Closed

An observational study to assess respiratory syncytial virus associated illness in adults with chronic obstructive pulmonary disease and or congestive heart failure.

RSV

Closed

A 1-year prospective, multicenter, observational registry study of treatment patterns and outcomes for patients with chronic obstructive pulmonary disease (STEP).

COPD

Closed

A clinical outcomes study to compare the effect of Fluticasone Furoate/Vilanterol inhalation powder 100/25 mcg with placebo on survival in subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease.

III-IV

COPD

Closed

A 12-week treatment, multi-center, randomized, double-blind, parallel-group, placebo and active controlled study to assess the efficacy, safety, and tolerability of QVA149 (indacaterol maleate / glycopyrronium bromide) in COPD patients with moderate to severe airflow limitation

II-III

COPD

Closed

A randomized, double-blind, (test products and placebo), chronic dosing(24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of PT003, PT005, and PT001 in subjects with moderate to very severe COPD, compared with placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 µg, open-label) as active control

III

COPD

Closed

Evaluation of SimplyFlo Transportable Oxygen Concentrator

COPD Device

Closed

A 12-week randomized, double-blind, placebo-controlled parallel-group, fixed-dosage study to evaluate the efficacy and safety of Armodafinil (50, 150, and 250 mg/day) As treatment for patients with excessive sleepiness assoicated with mild or moderate closed traumatic brain injury

III

Sleep Disorder

Closed

An evaluation of lung function and symptoms in patients with Chronic Obstructive Pulmonary Disease (COPD) on long-acting bronchodilator monotherapy <years

IV

COPD

Closed

A prospective, multinational, multicenter, double-blind, randomized, active-controlled trial to compare the effects of Lotrel (amlodipine / benazepril) to benazepril and hydrochlorothiazide combined on the reduction of cardiovascular morbidity and mortality in patients with high risk hypertension

III

Hypertension

Closed

A Phase IIIB, 12-Month, Double-blind, Double-dummy, Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 �g x 2 Actuations Twice-daily and 80/4.5 �g x 2 Actuations Twice-daily Compared to Formoterol TBH 4.5 �g x 2 Inhalations Twice-daily in COPD Subjects

III

COPD

Closed

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 (IGT)

III

Type II Diabetes Mellitus

Closed

A multicenter, randomized, double blind, parallel design trial to evaluate the blood pressure lowering efficacy comparing moderate versus aggressive treatment regimen of Exforge in patients uncontrolled on ARB monotherapy

III

Hypertension

Closed

A 12-week treatment, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of once daily indacaterol in patients with chronic obstructive pulmonary disease

II

COPD

Closed

A Randomized, Double-Blind, Parallel Group, Multicenter Study of the Effects of Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID (ADVAIR DISKUS™) in Comparison to Salmeterol 50mcg BID (SEREVENT DISKUS™) on the Rate of Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Following Hospitalization

III

Closed

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Armodafinil Treatment (150mg) in Imporving Clinical Condition Late in the Shift and in Improving Functional and Patient-Reported Outcomes in Adult Patients With Excessive Sleepiness Associated With Shift Work Disorder

III

Closed

A 12-week, randomized, double-blind, placebo-controlled, parallel group, multinational, phase IIb dose range finding study to evaluate the efficacy and safety of AZD9668 administered orally at 3 dose levels to patients with Chronic Obstructive Pulmonary Disease (COPD) on treatment with tiotropium

III

Closed

Efficacy and safety of inhaled human insulin (Exubera) compared with subcutaneous human insulin in the therapy of adult subjects with Type 1 or Type II Diabetes Mellitus and chronic obstructive pulmonary disease: A one year , multicenter, randomized, outpatient, open-label, parallel group comparative trial

II

COPD/DM

Closed

A SAFETY AND EFFICACY TRIAL EVALUATING THE USE OF APIXABAN FOR THE EXTENDED TREATMENT OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

III

Deep Vein Thrombosis

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 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

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in Asthmatic Adults with Symptomatic Human Rhinovirus Infection

II

Asthma

Closed

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, AND TOLERABILITY OF 2 DOSES OF ACLIDINIUM BROMIDE COMPARED WITH PLACEBO FOR 12 WEEKS IN PATIENTS WITH MODERATE TO SEVERE, STABLE CHRONIC OBSTRUCTIVE PULMONARY DISEASE FOLLOWED BY A 40-WEEK EVALUATION OF THE 2 ACLIDINIUM BROMIDE DOSES

II

COPD

Closed

A randomized, multi-center, parallel group, double blind, study to assess the safety of QMF Twisthaler ® (500/400 �g) and mometasone furoate Twisthaler ® (400 �g) in adolescent and adult patients with persistent asthma

II

Asthma

Closed

A randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 �g and 5 �g Tiotropium Inhalation Solution delivered by the Respimat ® Inhaler with Tiotropium inhalation capsules 18 µg delivered by the HandiHaler ®

IIIb

COPD

Closed

An Epidemiologic Study Of Xolair® (Omalizumab): Evaluating Clinical Effectiveness And Long-Term Safety In Patients With Moderate To Severe Asthma (EXCELS)

Observational Survey

Asthma

Closed

Effect of Roflumilast on Exacerbation Rate in Patients with COPD. A 52-week, double-blind study with 500 mcg Roflumilast once daily versus placebo

III

COPD

Closed

Algorithm in COPD Patients

COPD Device

Closed

Cough flow improvement in COPD

COPD Device

Closed

 
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