CLINICAL TRIALS PROFILE FOR FISH OIL TRIGLYCERIDES
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505(b)(2) Clinical Trials for FISH OIL TRIGLYCERIDES
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT00169299 ↗ | Herbal Alternatives for Menopause Symptoms (HALT Study) | Unknown status | National Center for Complementary and Integrative Health (NCCIH) | Phase 4 | 2001-06-01 | Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting. |
| OTC | NCT00169299 ↗ | Herbal Alternatives for Menopause Symptoms (HALT Study) | Unknown status | National Institute on Aging (NIA) | Phase 4 | 2001-06-01 | Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting. |
| OTC | NCT00169299 ↗ | Herbal Alternatives for Menopause Symptoms (HALT Study) | Unknown status | Group Health Cooperative | Phase 4 | 2001-06-01 | Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting. |
| OTC | NCT00169299 ↗ | Herbal Alternatives for Menopause Symptoms (HALT Study) | Unknown status | Kaiser Permanente | Phase 4 | 2001-06-01 | Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting. |
| New Formulation | NCT00627796 ↗ | Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly | Completed | University of Genova | Phase 4 | 2003-01-01 | Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG. |
| New Formulation | NCT00627796 ↗ | Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly | Completed | Federico II University | Phase 4 | 2003-01-01 | Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG. |
| New Combination | NCT01265537 ↗ | A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf | Completed | Astellas Pharma Canada, Inc. | N/A | 2011-06-24 | While the incidence of acute rejection and early graft loss have improved dramatically with the advent of newer immunosuppressant medications, improvements in long-term patient and allograft survival after kidney transplantation have not been achieved. The specific drug combination that provides the best outcomes with the least amount of side effects is not known. Each kidney transplant center uses the combination of drugs that they believe is optimal. This study is about identifying whether drugs that are currently approved for use in kidney transplantation can be used in a new combination safely and with potentially fewer side effects than the drug combinations that are currently used at St. Paul's Hospital and other transplant centres. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for FISH OIL TRIGLYCERIDES
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000620 ↗ | Action to Control Cardiovascular Risk in Diabetes (ACCORD) | Completed | Centers for Disease Control and Prevention | Phase 3 | 1999-09-01 | The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management. |
| NCT00000620 ↗ | Action to Control Cardiovascular Risk in Diabetes (ACCORD) | Completed | National Eye Institute (NEI) | Phase 3 | 1999-09-01 | The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management. |
| NCT00000620 ↗ | Action to Control Cardiovascular Risk in Diabetes (ACCORD) | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 3 | 1999-09-01 | The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management. |
| NCT00000620 ↗ | Action to Control Cardiovascular Risk in Diabetes (ACCORD) | Completed | National Institute on Aging (NIA) | Phase 3 | 1999-09-01 | The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management. |
| NCT00000620 ↗ | Action to Control Cardiovascular Risk in Diabetes (ACCORD) | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 1999-09-01 | The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management. |
| NCT00004266 ↗ | Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes | Completed | Hennepin County Medical Center, Minneapolis | Phase 3 | 1993-08-01 | OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients. |
| NCT00004266 ↗ | Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 3 | 1993-08-01 | OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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