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NCT ID: NCT00798161 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

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

The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

NCT ID: NCT00793390 Completed - Diabetes Clinical Trials

Case-Control Study of Inflammatory Breast Cancer in North Africa

Start date: November 17, 2008
Phase:
Study type: Observational

Background: - Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly aggressive form of breast cancer. - Three characteristics of IBC tumors their rapid progression, their extensive formation of new blood vessels, and the fact that these characteristics are present from the inception of the tumor make it an ideal model for studying factors associated with tumor aggressiveness. - This study is a collaboration among several institutions in the United States and North Africa that have extensive epidemiological experience and experience with IBC. Objectives: - To understand what causes certain types of breast conditions, including IBC. Eligibility: - Women 18 years of age and older with IBC and non-IBC and healthy women volunteers are eligible. Women who have had a previous diagnosis of any kind of breast cancer are excluded. Design: - Participants complete a questionnaire providing information about their background, including medical and reproductive history, family health history and lifestyle habits and undergo the following additional procedures: - Height, weight, hip and chest measurements. - Saliva sample collection to measure biological factors that may be related to breast conditions. - Breast examination and, if permission is given, photographs of affected breast. - Analysis of biopsied tissue for genetic and biochemical factors.

NCT ID: NCT00751881 Completed - Multiple Sclerosis Clinical Trials

An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis

TOWER
Start date: August 2008
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the effect of two doses of Teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in patients with relapsing MS. Key secondary objective is to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression. Other secondary objectives are: - To assess the effect of the two doses of teriflunomide in comparison to placebo on: - Fatigue; - Health-related quality of life, a measure of the impact of the patient's health on his or her overall well being. - To evaluate the safety and tolerability of teriflunomide.

NCT ID: NCT00722137 Completed - Clinical trials for Mantle Cell Lymphoma

Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma

Start date: May 1, 2008
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multicenter, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation.

NCT ID: NCT00713830 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 Sulfonylurea

GETGOAL-S
Start date: July 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 sulfonylurea without or with 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 sulfonylurea with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than (<) 7 percent (%); percentage of patients reaching HbA1c less than or equal to (<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG), glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a sub-study in all patients in selected centers; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

NCT ID: NCT00709683 Completed - Clinical trials for Diabetes Mellitus, Type 2

Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

Start date: May 2008
Phase: N/A
Study type: Observational

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.

NCT ID: NCT00708344 Completed - Hypertension Clinical Trials

ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

ACTUAL
Start date: June 2008
Phase: Phase 4
Study type: Interventional

To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.

NCT ID: NCT00703924 Completed - Clinical trials for Cutaneous Leishmaniasis

Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World

Start date: March 2003
Phase: Phase 2
Study type: Interventional

The objective of this study is to determine the effectiveness and toxicity of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.

NCT ID: NCT00700271 Completed - Hypertension Clinical Trials

Efficacy of a Combination of Amlodipine/Valsartan on 24H Blood Pressure Control With One Nocturnal or Diurnal Intake a Day

Start date: October 2007
Phase: Phase 4
Study type: Interventional

This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label, blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5 mg alone.

NCT ID: NCT00699998 Completed - Clinical trials for Acute Coronary Syndrome

A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects

TRILOGY ACS
Start date: June 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).