TO DETERMINE IF CARDIOVASCULAR RISK INDICES INCLUDING POSTPRANDIAL HYPERTRIGLYCERIDAEMIA ARE MODIFIED FAVOURABLY BY NICOTINIC ACID (NIACIN) IN PATIENTS WITH POLYCYSTIC OVARY SYNDROME (PCOS)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015729-35-GB

Enrollment

Registered

2009-10-01

Start date

2009-11-23

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome

Interventions

Trade Name: Tredaptive (nicotinic acid/ laropiprant)- (MK524A) Product Name: tredaptive Pharmaceutical Form: Tablet INN or Proposed INN: NICOTINIC ACID

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18-50 year Polycystic ovary syndrome (evidence of anovulation, clinical or biochemical hyperandrogenism, polycystic ovaries on ultrasound scanning which meets the PCOS diagnostic criteria of Rotterdam consensus statement) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy/ who is trying to conceive/Breast Feeding 2) History of cardiovascular, renal, hepatic and active thyroid disease 3) History of Gout 4) History of alcohol abuse 5) History of Diabetes 6) History of bleeding disorders/ active peptic ulcers 7) Patient on antihypertensive medications 8) Patient on anticoagulants 9) History of allergy to nicotinic acid/ laropiprant/food 10) Patient on any hormonal replacement or oral contraceptive pills or cholesterol lowering agents 11) History of smoking more than 15 pack year 12) Unwilling for GP to be informed

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. The prevalence of persistent elevation of fat (triglycerides) following a meal in patients with polycystic ovary syndrome and its relationship to insulin resistance 2. To determine if the dyslipidaemic cardiovascular risk indices including postprandial hypertriglyceridaemia are reversed favourably by nicotinic acid (niacin) therapy ; Secondary Objective: 1. To determine the effect of nicotinic acid on insulin resistance and other markers of cardiovascular risk such as hs CRP 2. To determine the effect of nicotinic acid on endothelial function ; Primary end point(s): 1) Improvement of lipid profile, reduction of fasting and postprandial triglyceride, low density lipoproteins and rise of high density lipoproteins 2) Improvement of hs c reative protein 3) Improvement of endothelial function at the end of study	—

Measure

Time frame

Main Objective: 1. The prevalence of persistent elevation of fat (triglycerides) following a meal in patients with polycystic ovary syndrome and its relationship to insulin resistance 2. To determine if the dyslipidaemic cardiovascular risk indices including postprandial hypertriglyceridaemia are reversed favourably by nicotinic acid (niacin) therapy ; Secondary Objective: 1. To determine the effect of nicotinic acid on insulin resistance and other markers of cardiovascular risk such as hs CRP 2. To determine the effect of nicotinic acid on endothelial function ; Primary end point(s): 1) Improvement of lipid profile, reduction of fasting and postprandial triglyceride, low density lipoproteins and rise of high density lipoproteins 2) Improvement of hs c reative protein 3) Improvement of endothelial function at the end of study

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026