Population-Based Modeling of Cholesterol Lowering in the United States
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00005463 |
Recruitment Status
:
Completed
First Posted
: May 26, 2000
Last Update Posted
: February 18, 2016
|
Tracking Information | |||
---|---|---|---|
First Submitted Date | May 25, 2000 | ||
First Posted Date | May 26, 2000 | ||
Last Update Posted Date | February 18, 2016 | ||
Study Start Date | August 1991 | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures | Not Provided | ||
Original Primary Outcome Measures | Not Provided | ||
Change History | Complete list of historical versions of study NCT00005463 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures | Not Provided | ||
Original Secondary Outcome Measures | Not Provided | ||
Current Other Outcome Measures | Not Provided | ||
Original Other Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Population-Based Modeling of Cholesterol Lowering in the United States | ||
Official Title | 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. |
||
Study Type | Observational | ||
Study Design | Not Provided | ||
Target Follow-Up Duration | Not Provided | ||
Biospecimen | Not Provided | ||
Sampling Method | Not Provided | ||
Study Population | Not Provided | ||
Condition |
|
||
Intervention | Not Provided | ||
Study Groups/Cohorts | Not Provided | ||
Publications * |
|
||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status | Completed | ||
Enrollment | Not Provided | ||
Original Enrollment | Not Provided | ||
Actual Study Completion Date | May 1993 | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria | No eligibility criteria | ||
Sex/Gender |
|
||
Ages | up to 100 Years (Child, Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | Not Provided | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT00005463 | ||
Other Study ID Numbers | 4907 R01HL046315 ( U.S. NIH Grant/Contract ) |
||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor | National Heart, Lung, and Blood Institute (NHLBI) | ||
Collaborators | Not Provided | ||
Investigators | Not Provided | ||
PRS Account | National Heart, Lung, and Blood Institute (NHLBI) | ||
Verification Date | September 2002 |