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NCT ID: NCT00239629 Completed - Clinical trials for Postmenopausal Osteoporosis

Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial

Start date: September 2005
Phase: Phase 4
Study type: Interventional

The aim of this study is to directly compare the bone forming effects of 20 microg/day of teriparatide with those of 2 g/day strontium ranelate as measured by the histomorphometric variables and biochemical bone formation markers after 6 months of therapy in postmenopausal women with osteoporosis.

NCT ID: NCT00239538 Completed - Hypertension Clinical Trials

SMOOTH - Blood Pressure Control in Diabetic/Obese Patients

Start date: January 2003
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to demonstrate that telmisartan 80 mg combined with hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to valsartan 160 mg combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval at the end of a 10-week treatment period in mild-to-moderate hypertensive, overweight or obese patients with type 2 diabetes mellitus

NCT ID: NCT00237224 Completed - Breast Cancer Clinical Trials

Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole

Start date: February 2003
Phase: Phase 4
Study type: Interventional

To evaluate safety and efficacy (measured by clinical tumor response) of letrozole daily dose, 2.5 mg in postmenopausal patients with primary (untreated) breast cancer.

NCT ID: NCT00232596 Completed - Clinical trials for Partial-Onset Seizures

Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy

RESTORE1
Start date: September 2005
Phase: Phase 3
Study type: Interventional

This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

NCT ID: NCT00232180 Completed - Heart Failure Clinical Trials

A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines

EMPHASIS-HF
Start date: March 2006
Phase: Phase 3
Study type: Interventional

In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients. The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population. On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone

NCT ID: NCT00226330 Terminated - Clinical trials for Diabetes Mellitus, Type 2

GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

Start date: March 2005
Phase: Phase 3
Study type: Interventional

This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.

NCT ID: NCT00224978 Completed - Clinical trials for Glioblastoma Multiforme

Chloroquine for Treatment of Glioblastoma Multiforme

Start date: January 2005
Phase: Phase 3
Study type: Interventional

Chloroquine is a strong lysosomotropic and DNA-intercalating agent in experimental studies (Neurosurgical Focus 14(2): February, 2003) and an open-label clinical trial the investigators have demonstrated a strong adjuvant effect of chloroquine on the therapy of malignant gliomas. This study will assess in a randomized, placebo-controlled, double-blind study the effects of chloroquine as adjuvant to the conventional therapy of Glioblastoma Multiforme.

NCT ID: NCT00223977 Completed - Clinical trials for Iron Deficiency Anemia

2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

Start date: December 2003
Phase: Phase 2/Phase 3
Study type: Interventional

This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

NCT ID: NCT00223964 Completed - Anemia Clinical Trials

Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients

Start date: June 2003
Phase: Phase 4
Study type: Interventional

This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.

NCT ID: NCT00221000 Completed - Clinical trials for Rheumatoid Arthritis

Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis

RA-1
Start date: August 2003
Phase: Phase 2
Study type: Interventional

Rheumatoid arthritis (RA) is a systemic autoimmune inflammatory disorder that can cause substantial pain and joint tenderness, significant joint damage, and serious disability. The treatment goals are minimization of the signs and symptoms of the disease, and the reduction of irreversible joint damage. As the understanding of the pathophysiological mechanisms underlying RA is elucidated, the opportunity to target specific inflammatory processes with new therapies has improved. Rheumatoid arthritis is a T cell-mediated autoimmune disease and there are various therapies, including newer experimental therapies, which target either the activation of T cells or the neutralization of their effector mechanisms. These newer therapies have shown benefit in human and animal models of RA. Extracorporeal photoimmune therapy (ECP) has been shown to be safe and effective in the palliative treatment of the skin manifestations of cutaneous T cell lymphoma. Experimental studies have also demonstrated activity of ECP treatment in several T cell mediated diseases including graft versus-host disease, rejection after organ transplantation, and selected autoimmune diseases. This study will evaluate a cell-based therapy (ECP) in patients who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) and biological agents to determine if ECP treatment can reduce the signs and symptoms of RA in this refractory patient population.