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Population-Based Modeling of Cholesterol Lowering in the United States
| Tracking Information | |||
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| First Received Date ICMJE | May 25, 2000 | ||
| Last Updated Date | February 17, 2016 | ||
| Start Date ICMJE | August 1991 | ||
| Primary Completion Date | Not Provided | ||
| Current Primary Outcome Measures ICMJE | Not Provided | ||
| Original Primary Outcome Measures ICMJE | Not Provided | ||
| Change History | Complete list of historical versions of study NCT00005463 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Population-Based Modeling of Cholesterol Lowering in the United States | ||
| Official Title ICMJE | Not Provided | ||
| Brief Summary | To evaluate the cost-effectiveness of cholesterol-lowering strategies in the United States population. The study used the Coronary Heart Disease (CHD) Policy Model, a state-transition computer simulation model used to obtain forecasts of the public health impact and economic cost of CHD in the United States population. | ||
| Detailed Description | BACKGROUND: The study was part of an Institute-initiated Request for Applications (RFA) titled "Cost-Effective Strategies of Cholesterol-Lowering" released by the NHLBI in 1990. The RFA was stimulated by the controversy concerning costs and cost-effectiveness that followed the 1987 report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. The RFA was intended to support a broad and thorough quantitative exploration of the potential health benefits and costs of cholesterol-lowering from multiple perspectives. DESIGN NARRATIVE: The study added to the CHD Policy Model the capability to model the consequences of reductions in LDL cholesterol and increases in HDL/LDL ratios in the United States population. The CHD Policy Model was used for several studies, including: to compare the implications of using alternative epidemiologic studies as the basis for estimating the association between cholesterol levels and CHD risk; to derive cutting points for initiating cholesterol reduction, specific to age, sex, and CHD risk factors, and based on cost-effectiveness criteria; to compare the cost-effectiveness of specific targeted and population-wide strategies for cholesterol reduction; to incorporate the effects of treatments on quality of life, including both adverse effects of cholesterol-lowering drugs and reductions in CHD morbid events; and finally, to perform a cost-effectiveness analysis of cholesterol screening, incorporating costs of screening, effects of measurement error on misclassification of patients, and variations in individual cholesterol levels over time. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record. |
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| Study Type ICMJE | Observational | ||
| Study Design ICMJE | Not Provided | ||
| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Not Provided | ||
| Study Population | Not Provided | ||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | Not Provided | ||
| Completion Date | May 1993 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | No eligibility criteria | ||
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| Ages | up to 100 Years (Child, Adult, Senior) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Not Provided | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00005463 | ||
| Other Study ID Numbers ICMJE | 4907 R01HL046315 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | National Heart, Lung, and Blood Institute (NHLBI) | ||
| Verification Date | September 2002 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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