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NCT ID: NCT00765947 Completed - Clinical trials for Essential Hypertension ( Mild to Moderate)

Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

Start date: September 2008
Phase: Phase 4
Study type: Interventional

This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure [msSBP] ≥ 140 mmHg and < 180 mmHg and/or mean sitting Diastolic Blood Pressure [msDBP] ≥ 90 and <110 mmHg).

NCT ID: NCT00765674 Completed - Hypertension Clinical Trials

Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

Start date: September 2008
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.

NCT ID: NCT00763815 Completed - Clinical trials for Diabetes Mellitus Type 2

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

GETGOAL-P
Start date: September 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

NCT ID: NCT00763451 Completed - Clinical trials for Diabetes Mellitus, Type 2

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

GETGOAL-F1
Start date: September 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two steps dose titration regimen at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to metformin on glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

NCT ID: NCT00762840 Recruiting - Clinical trials for Periapical Periodontitis

Safety and Efficacy of the Apexum Ablator

Start date: October 2006
Phase: N/A
Study type: Interventional

The study is designed to test the hypothesis that there is a difference in healing kinetics and healing rate between teeth treated by conventional endodontic procedure alone and those in which such procedure was supplemented with the Apexum Ablator protocol

NCT ID: NCT00762411 Completed - Alzheimer's Disease Clinical Trials

Effects of LY450139, on the Progression of Alzheimer's Disease as Compared With Placebo

IDENTITY-2
Start date: September 2008
Phase: Phase 3
Study type: Interventional

Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some patients. The buildup of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some patients. In this trial, patients who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all patients could eventually receive active drug. Each patient's participation could last approximately 2 years. Patients taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All patients who completed this study had the option to continue receiving semagacestat by participating in an open label study. Preliminary results from this study (LFBC) (and another similar study LFAN [NCT00594568]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. LFBC, LFAN and open label LFBF (NCT01035138) have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol.

NCT ID: NCT00761683 Terminated - Endometriosis Clinical Trials

Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS

ESIS
Start date: October 2008
Phase: N/A
Study type: Observational

To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for pelvic tenderness and indurations; to observe the reduction in the proportion of patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated with Zoladex 3.6 mg.

NCT ID: NCT00760968 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety of TAK-783 in Subjects With Rheumatoid Arthritis

Start date: August 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of TAK-783, once daily (QD), taken in combination with methotrexate in subjects with rheumatoid arthritis.

NCT ID: NCT00757731 Completed - Clinical trials for Fibromyalgia Syndrome

FMS European Long-Term Study

Start date: September 2006
Phase: Phase 3
Study type: Interventional

Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.

NCT ID: NCT00755755 Completed - Uterine Myomas Clinical Trials

PGL4001 Versus Placebo in Uterine Myomas

PEARLI
Start date: October 2008
Phase: Phase 3
Study type: Interventional

This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.