Clinical trial · Interventional
Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome
To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic Ovary Syndrome ( PCOS)
NCT01118598CI-TRIAL-00039483completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its lipid lowering as well as via pleiotropic effects in patients with polycystic ovary syndrome (PCOS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| tredaptive (nicotinic acid/ laropiprant) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- placebo arm
- description
- this group will receive placebo as per protocol
- interventionNames
- Drug: placebo
- type
- ACTIVE_COMPARATOR
- label
- tredaptive
- description
- tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
- interventionNames
- Drug: tredaptive (nicotinic acid/ laropiprant)
Primary outcomes (1)
- measure
- Reduction in postprandial triglyceride
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Females aged between 18 - 50 years * Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement Exclusion Criteria: * Pregnancy/trying to conceive/breast feeding * History of cardiovascular, renal, hepatic and active thyroid disease * History of gout * History of alcohol abuse * History of diabetes * History of allergy to nicotinic acid/laropiprant or food * History of bleeding disorders/active peptic ulcers * Patient on antihypertensive medications * Patient on anticoagulants * Patient on any hormonal replacement or oral contraceptive pills or cholesterol lowering agents * History of smoking more than 15 pack year * Unwilling for GP to be informed
References
Publications (1)
- RESULTAye MM, Kilpatrick ES, Afolabi P, Wootton SA, Rigby AS, Coady AM, Sandeman DD, Atkin SL. Postprandial effects of long-term niacin/laropiprant use on glucose and lipid metabolism and on cardiovascular risk in patients with polycystic ovary syndrome. Diabetes Obes Metab. 2014 Jun;16(6):545-52. doi: 10.1111/dom.12255. Epub 2014 Feb 9. PMID 24401089