Trial Outcomes & Findings for Study of Lipid Control in Hyperlipidemic Participants (MK-0653-179) (NCT NCT01436253)

NCT ID: NCT01436253

Last Updated: 2022-02-09

Results Overview

Target total cholesterol value was \<4.5 mmol/L and target low densisty lipoprotein (LDL) value was \<2.5 mmol/L

Recruitment status

COMPLETED

Target enrollment

2196 participants

Primary outcome timeframe

Baseline and Month 3

Results posted on

2022-02-09

Participant Flow

Participant milestones

Participant milestones
Measure
All Participants
Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
Overall Study
STARTED
2196
Overall Study
COMPLETED
1897
Overall Study
NOT COMPLETED
299

Reasons for withdrawal

Reasons for withdrawal
Measure
All Participants
Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
Overall Study
Lost to Follow-up
182
Overall Study
Not meeting all eligibility criteria
117

Baseline Characteristics

Study of Lipid Control in Hyperlipidemic Participants (MK-0653-179)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=1897 Participants
Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
Age, Customized
30-44 Years
118 Participants
n=5 Participants
Age, Customized
45-64 Years
1063 Participants
n=5 Participants
Age, Customized
>=65 Years
716 Participants
n=5 Participants
Sex/Gender, Customized
Female
1042 Participants
n=5 Participants
Sex/Gender, Customized
Male
770 Participants
n=5 Participants
Sex/Gender, Customized
Unknown
85 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Month 3

Population: Participants meeting all inclusion and exclusion criteria.

Target total cholesterol value was \<4.5 mmol/L and target low densisty lipoprotein (LDL) value was \<2.5 mmol/L

Outcome measures

Outcome measures
Measure
All Participants
n=1897 Participants
Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
Percentage of Participants Achieving Target Lipid Values
46.8 Percentage of participants
Interval 44.6 to 49.0

PRIMARY outcome

Timeframe: Baseline and Month 3

Population: Participants meeting all inclusion and exclusion criteria.

Cardiovascular risk assessment to determine the 10-year risk for developing cardiovascular disease was done using Framingham risk scoring; categories scored are age, high density lipoprotein (HDL) cholesterol value, total cholesterol value, history of cigarette smoking, and systolic blood pressure. The total of all the points for each risk factor is used to assign a percentage of risk for the occurence of cardiovascular disease within 10 years. Total points for men range from -9 to +37 and for women from -8 to +46; \>=17 total points for men, and \>=25 total points for women indicates a \>=30% risk of developing cardiovascular disease.

Outcome measures

Outcome measures
Measure
All Participants
n=1897 Participants
Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
Percentage of Participants With Reduced Cardiovascular Risk
51.1 Percentage of participants

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

  • Principal investigator is a sponsor employee No Investigator may publish or disclose any study information without permission from the Sponsor.
  • Publication restrictions are in place

Restriction type: OTHER