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Clinical Trials

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Current View: Completed Studies

Acute Coronary Syndrome

(6/1/1999 - 12/1/2002) Phase III. Evaluating the long term safety and efficacy of an Investigational Product combination in high risk patients after a heart attack / Myocardial Infarction. Males and Females with previous heart attack / Myocardial Infarction.

Allergies

(5/1/2008 - 12/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product in subjects with grass pollen rhinoconjunctivitis. Males and Females, 18 to 50 years of age, with grass pollen allergies.

Anemia

(5/1/2005 - 4/1/2009) Phase III. A trial to reduce cardiovascular events with Investigational Product therapy. Males and Females with Type II Diabetes and Anemia related to Chronic Kidney Disease.

(12/1/2006 - 8/1/2008) Phase III. Aplastic Anemia and MDS observational study. Males and Females, 10 years of age and older, with a diagnosis of Aplastic Anemia or MDS.

Ankle Sprain

(5/1/2008 - 11/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product as a patch therapy in patients with recent ankle sprain. Males and Females, 18 years of age and older, who have experienced an ankle sprain within the past 48 hours.

(2/1/2009 - 6/1/2009) Phase III. Evaluating the efficacy and safety of patch therapy for the topical treatment of mild to moderate Ankle Sprain. Males and Females, 17 to 75 years of age, have experienced an ankle sprain within 60 hours.

Asthma

(9/1/2006 - 5/1/2007) Phase III. Studying the effects of an Investigational nasal spray on common cold symptoms and asthma exacerbations when exposed to someone with a cold. Males and Females, 6 to 65 years of age, a diagnosis of asthma and taking asthma medication.

Atrial Fibrillation

(9/1/2007 - 10/1/2008) Phase III. Evaluating the efficacy and safety of an Investigational nasal spray versus placebo in addition to antibiotics in relieving symptoms of Sinusitis. Males and Females, 12 years of age and older, with symptoms of Sinusitis.

(8/1/2005 - 1/1/2008) Phase III. Evaluating the efficacy of Investigational Product for the prevention of hospitalization or death in patients with Atrial Fibrillation/Atrial Flutter. Males and Females, 70 years of age and older (with cardiovascular risk factors) or 75 years of age (with or without risk factors), with Atrial Fibrillation or Atrial Flutter.

(5/1/2008 - 8/1/2010) Phase III. Evaluating efficacy and safety of Investigaional Product versus warfarin in preventing cardiac events in patients with Atrial Fibrillation. Males and Females diagnosed with Atrial Fibrillation.

(10/1/2007 - 6/1/2008) Phase III. Evaluating the superiority of Investigational Product when given to subjects with active Rheumatoid Arthritis (RA). Males and Females, 18 years of age and older, with active Rheumatoid Arthritis.

Constipation

(2/9/2009 - 8/31/2010) Phase III. An open label study to evaluate the safety of Investigational Product in treating Opioid Induced Constipation. Males and Females, 18 years of age and older with a history of constipation and pain on opioid therapy.

COPD

(4/1/2009 - 1/1/0001) Phase III. A 12 week study to evaulate the safety and effectiveness of an Investigational Product when used for once daily treatment of COPD and in combination with Spiriva or placebo. Males and Females, 40 years of age and older, with a diagnosis of COPD or Chronic Obstructive Pulmonary Disease.

Deep Vein Thrombosis

(5/1/2008 - 2/1/2009) Phase III. Evaluating the use of Investigational Product for the treatment of Deep Vein Thrombosis and Pulmonary Embolism. Males and Females, 18 years of age and older, with Deep Vein Thrombosis and Pulmonary Embolism.

Diabetes (Type II)

(10/1/2005 - 12/1/2005) Phase III. Evaluating the efficacy and safety of different titrations of Investigational Product in patients with Type II Diabetes. Males and Females, 18 years of age and older, with Type II Diabetes.

(6/1/2006 - 12/1/2006) Phase III. Evaluating the efficacy, safety and tolerability of three dose levels of Investigational Product in subjects with Type II Diabetes. Males and Females with a diagnosis of Type II Diabetes.

(1/1/2002 - 9/1/2009) Phase III. Evaluating the efficacy and safety of long term administration of a combination of Investigational Products in the prevention of Diabetes and Cardiovascular Outcome in patients with impaired glucose tolerance. Males and Females with Impaired Glucose Tolerance (IGT).

(5/1/2004 - 12/1/2009) Phase III. Evaluating the reduction in occurrence of diabetic macular edema. Males and Females with diabetic macular edema.

(8/1/2006 - 9/1/2007) Phase III. Comparing the efficacy of an Investigational Product versus TZD as add-on therapy in patients with Type II Diabetes currently on Metformin therapy. Males and Females, 18 to 80 years of age, with Type II Diabetes.

(7/1/2008 - 1/1/0001) Phase III. Evaluating the efficacy of an Investigational Product when used in combination with Metformin, ACTOS or Avandia. Males and Females, 18 years of age and older, with Type II Diabetes taking Metformin, ACTOS or Avandia.

(12/1/2009 - 8/31/2010) Phase II. A multi-center, double-blind, placebo-controlled, randomized study to compare the effect of a subcutaneous IP administration to placebo in patients with Impaired Glucose Tolerance or patients with Type 2 Diabetes treated with differing baseline diabetes therapies. Males and Females, 18 to 74 years of age with Impaired Glucose Tolerance or Type II Diabetes.

(2/1/2007 - 4/1/2008) Phase II. Evaluating weekly treatment of an Investigational Product in subjects with Type II Diabetes. Males and Females, 18 to 80 years of age, with Type II Diabetes and currently on Metformin therapy.

(6/1/2007 - 8/1/2007) Phase III. Evaluating the efficacy and safety of Investigational Product in combination with ACTOS in subjects with Type II Diabetes. Males and Females, 18 to 80 years of age, with Type II Diabetes.

Fibromyalgia

(7/1/2008 - 8/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product versus placebo in patients diagnosed with Fibromyalgia as assessed by the American College of Rheumatology (ACR). Males and Females, 18 years of age and older, with diagnosis of Fibromyalgia.

High Blood Pressure

(5/1/2006 - 7/1/2007) Phase III. Evaluating the efficacy and safety of a triple therapy combination drug in comparison to 3 sets of double therapy combinations in patients with moderate to severe hypertension. Males and Females, 18 to 86 years of age, with Hypertension.

(11/1/2006 - 3/1/2008) Phase III. Evaluating the efficacy and safety of different doses of 2 separate Hypertensive medications or a combination of those medications. Males and Females, 18 years of age and older with Stage II Hypertension.

(1/1/2003 - 3/1/2004) Phase III. Evaluating the efficacy and safety of two Investigational Products combined and alone in patients with Hypertension. Males and Females with Stage II Hypertension.

(6/1/1999 - 1/1/2005) Phase III. Evaluating the effect of an Investigational Product in preventing Hypertension. Males and Females with Stage II Hypertension.

(10/1/2002 - 11/1/2002) Phase III. Evaluating the efficacy of dosing two Investigational Products compared to uptitration of one Investigational Product in patients with Hypertension. Males and Females with Stage II Hypertension.

(2/1/2008 - 3/1/2008) Phase III. Evaluating the incidence of hypotension in elderly hypertensive patients following administration of a combination of COREG CR and lisinopril. Males and Females, 65 years of age and older, with Hypertension.

(12/1/2008 - 2/10/2010) Phase III. Evaluating efficacy and safety of Investigational Product in comparison to Amlodipine (Norvasc) in patients with Hypertension and Diabetes. Males and Females, 18 years of age and older with Hypertension and Type II Diabetes.

(7/1/2009 - 3/1/2010) Phase IV. A trial to compare 12 weeks of Investigational Product to Placebo when added to a stable regimen of Lisinopril or Losartan in patients with Hypertension. Males and Females, 18 to 85 years of age with Hypertension.

(10/1/2008 - 4/1/2009) Phase III. Evaluating the efficacy and safety of Investigational Product in comparison to HCTZ in subjects with stage 2 systolic Hypertension. Males and Females, 55 years of age and older, with Hypertension.

(4/1/2008 - 10/1/2008) Phase III. Comparison trial of subjects with Hypertension who achieve target blood pressure while receiving either COREG CR + lisinopril or lisinopril monotherapy. Males and Females, 18 to 80 years of age and older, with Stage 1 or 2 Essential Hypertension.

(4/1/2008 - 9/1/2009) Phase III. Evaluating efficacy and tolerability of Investigational Product in comparison with Carvedilol (Coreg) in patients with Coronary Artery Disease and Hypertension. Males and Females, 18 to 85 years of age, with a history of Coronary Artery Disease and Hypertension.

High Cholesterol

(4/1/2000 - 8/1/2000) Phase III. Evaluating the effects of an Investigational Product on bone density and cholesterol. Males and Females with low bone density and high cholesterol.

Low Sodium

(7/1/2007 - 12/1/2008) Phase IIIb. Studying the effects of titrated Investigational Product on function of hyponatremic patients. Males and Females, 50 years of age and older, with Hyponatremia (Low Sodium).

(7/1/2008 - 12/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product versus placebo in patients with Hyponatremia (low sodium) due to SIADH. Males and Females, 18 years of age and older, with chronic Hyponatremia (low sodium).

(8/1/2009 - 8/1/2010) Phase III. A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Investigational Product in Subjects with Euvolemic Hyponatremia. Males and Females, 18 years of age and older, with low sodium levels.

Osteoarthritis

(2/1/2008 - 11/1/2008) Phase III. Evaluating the efficacy of Investigational Product in subjects with Osteoarthritis of the Knee. Males and Females, 40 years of age and older, with Osteoarthritis of the Knee.

(6/1/2008 - 5/1/2009) Phase II. A 1-year extension study to evaluate the safety, tolerability and effectiveness of Investigational Product in subjects with Osteoarthritis of the Knee. Males and Females, who have successfully completed the Core trial, with Osteoarthritis of the Knee.

(2/9/2009 - 8/31/2010) Phase III. Evaluating the efficacy and safety of Investigational Product alone or in combination with NSAIDs versus NSAIDs alone in patients with Osteoarthritis of the Knee or Hip. Males and Females, 18 years of age and older, with Osteoarthritis of the Knee and Hip.

Osteopenia

(10/1/2004 - 10/1/2007) Phase III. Evaluating the efficacy and safety of IV Investigational Product administered either once or twice in a two year time period in the prevention of bone loss. Postmenopausal Females, 45 years of age and older, with Osteopenia.

Osteoporosis

(6/1/2003 - 6/1/2005) Phase III. An open label extension trial of the safety and efficacy of Investigational Product in women with postmenopausal Osteoporosis. Postmenopausal Females with Osteoporosis who participated and successfully completed the Core trial.

(2/1/2004 - 8/1/2005) Phase III. Evaluating the effects of calcium supplementation on the efficacy and safety of Investigational Product in postmenopausal women with Osteoporosis. Postmenopausal Females with Osteoporosis.

(5/1/2004 - 11/1/2009) Phase III. Evaluating the effects of Investigational Product on vertebral fracture and breast cancer incidence in postmenopausal women with Osteoporosis or low bone density. Postmenopausal Females, 60 to 85 years of age, with Osteoporosis or low bone density.

(1/1/2003 - 2/1/2005) Phase III. Evaluating the efficacy and safety of two Investigational Product dose regimens versus oral Investigational Product in postmenopausal Osteoporosis. Postmenopausal Females with Osteoporosis.

(1/1/1996 - 1/1/2000) Phase III. Evaluating the efficacy of an Investigational Product in the treatment of Osteoporosis in postmenopausal women. Postmenopausal Females with Osteoporosis.

(10/1/2000 - 9/1/2003) Phase III. Evaluating the effect of Investigational Product on fracture incidence in postmenopausal Osteoporosis. Postmenopausal Females with Osteoporosis.

(1/1/2002 - 4/1/2007) Phase III. Evaluating the efficacy and safety of Investigational Product in the treatment of Osteoporosis in postemenopausal women taking calcium plus Vitamin D. Postmenopausal Females with Osteoporosis.

(12/1/2004 - 1/1/2006) Phase III. An open label study to investigate patient satisfaction with a transition from once-weekly Osteoporosis therapy to once-monthly dosed Osteoporosis therapy. Postmenopausal Females with Osteoporosis or Osteopenia on current therapy for their diagnosis.

(7/1/2006 - 4/1/2008) Phase III. Evaluating the safety and efficacy of transitioning therapy from Alendronate to Investigational Product in postmenopausal women with low bone mineral density. Postmenopausal Females, 55 years of age and older, with Osteoporosis or low bone mineral density.

(5/1/2007 - 12/1/2009) Phase III. Evaluating the effect on renal function of alendronate in different administrations in postmenopausal women with Osteoporosis or low bone mineral density. Postmenopausal Females, 65 years of age and older, with Osteopororis or low bone mineral density.

(9/1/2007 - 8/1/2010) Phase III. Open-label study to evaluate the adherence, preference and satisfaction of Investigational Product and Alendronate (Fosomax) in postmenopausal women with low bone mineral density. Postmenopausal Females, 55 years of age and older, with Osteoporosis or low bone mineral density.

(3/1/2006 - 12/1/2008) Phase IV. An observational study to determine the pattern of care and outcomes associated with bone loss in postmenopausal women. Postmenopausal Females, 18 years of age and older, currently taking Calcium or Osteoporosis medication to prevent bone loss.

(2/1/2005 - 4/1/2008) Phase IV. Open label extension trial evaluating two IV Investigational Product regimens in women with postmenopausal Osteoporosis who have completed the Core Osteoporosis trial. Postmenopausal Females with Osteoporosis who have successfully completed the Core Osteoporosis trial.

(5/1/2005 - 8/1/2006) Phase III. Comparing the efficacy and safety of once monthly oral Investigational Product versus once weekly oral Investigational Product in postmenopausal women with Osteoporosis. Postmenopausal Females, 55 to 84 years of age, and are naive to Osteoporosis medication.

(5/1/2005 - 7/1/2009) Phase III. A 3 year extension trial to evaluate the long term safety and efficacy of Investigational Product in the treatment of Osteoporosis in postmenopausal women taking calcium and vitamin D. Postmenopausal Females with Osteoporosis who have successfully completed the Core Osteoporosis trial.

Other

Vaccine

(4/1/2008 - 4/16/2010) Phase III. Evaluating safety, tolerability and immunogenicity of an Investigational Vaccine compared with an FDA-approved vaccine. Males and Females, 70 years of age and older, with previous dose of FDA-approved vaccine.

Overactive Bladder

(10/1/2007 - 12/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product as an "add-on" therapy in men with symptoms of Overactive Bladder. Males, 40 years of age and older, with symptoms of Overactive Bladder on alpha blocker therapy.

Pink Eye

(5/1/2006 - 5/1/2007) Phase III. A study to evaluate the effect of an Investigational Eye Drop in comparison to Vigomox in treating Pink Eye (Bacterial Conjunctivitis). Males and Females, 1 year of age and older, with active Pink Eye (Bacterial Conjunctivitis).

Rheumatoid Arthritis

(5/1/2004 - 3/1/2005) Phase III. Evaluating the effect of Investigational Product versus placebo on daytime function in subjects with insomnia related to Rheumatoid Arthritis. Males and Females with Insomnia related to Rheumatoid Arthritis.

Sinusitis

(8/1/2000 - 11/1/2000) Phase III. Evaluating the effect of a tablet Investigational Product in treating viral upper respiratory illness in adults. Adult Males and Females with Viral Upper Respiratory Illness.

Tendonitis/Bursitis

(12/1/2006 - 5/1/2007) Phase III. Efficacy, tolerability and safety of a topical patch in treating pain from Tendonitis or Bursitis of the shoulder, elbow or knee. Males and Females, 18 years of age and older, with a diagnosis within 15 days of Tendonitis or Bursitis of the shoulder, elbow or knee.

(5/1/2008 - 11/1/2008) Phase III. Evaluating the efficacy and safety of Investigational Product as a patch therapy in patients with recent shoulder pain. Males and Females, 18 years of age and older, who have experienced acute shoulder pain within the past 48 hours.

Wrist Sprain/Strain

(2/1/2009 - 7/1/2009) Phase III. Evaluating the efficacy and safety of patch therapy for the topical treatment of pain due to mild to moderate wrist sprain, strain or contusion. Males and Females with a wrist sprain, strain or contusion within the past 60 hours.

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