Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Stephen L Atkin, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01118598
First received: May 4, 2010
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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).


Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: tredaptive (nicotinic acid/ laropiprant)
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic Ovary Syndrome ( PCOS)

Resource links provided by NLM:


Further study details as provided by Hull and East Yorkshire Hospitals NHS Trust:

Primary Outcome Measures:
  • Reduction in postprandial triglyceride [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Postprandial triglyceride will be measured using meal test.


Secondary Outcome Measures:
  • Reduction in high sensitivity C-reactive protein (CRP) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in peripheral arterial tone (PAT- index) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Peripheral arterial tone (PAT- index) will be measured using ENDO PAT 2000 before and after intervention


Enrollment: 34
Study Start Date: June 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo arm
this group will receive placebo as per protocol
Drug: placebo
placebo tablet one a day for first 4 weeks followed by two a day for 8 weeks
Active Comparator: tredaptive
tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
Drug: tredaptive (nicotinic acid/ laropiprant)
tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
Other Name: tredaptive

Detailed Description:

Polycystic ovary syndrome is a common hormone problem in young women and, as a result of it, they can experience irregular periods, reduced fertility, acne and increased body hair. Frequently, increased weight is a feature. Research suggests that they could have a higher risk of diabetes, high cholesterol and cardiovascular disease such as high blood pressure, angina, heart attack and stroke.

The fat from the diet is transported from the stomach into the blood and then taken up by the liver, muscles and fat tissues to store or use as an energy source. Delayed removal of fat from the circulation resulting rise of fat after a meal has been known to happen in PCOS. High fats after a meal are a strong risk factor for cardiovascular disease.

Niacin has been in clinical use to lower bad cholesterol and to increase good cholesterol for many years. It has been proved to be effective in reducing risks of heart disease in patients with diabetes. However the effect of niacin on reducing cardiovascular risks and reducing fat level after a meal in PCOS has not been studied and this is why we plan to do this research.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118598

Locations
United Kingdom
Hull & East Yorkshire Hospitals NHS Trust
Hull, United Kingdom, HU3 2RW
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Stephen L Atkin, FRCP, PhD University of Hull
  More Information

No publications provided

Responsible Party: Stephen L Atkin, Professor of Diabetes, Endocrinology and Metabolism, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01118598     History of Changes
Other Study ID Numbers: R0920 PCOS & Niacin, ISRCTN37787683
Study First Received: May 4, 2010
Last Updated: September 10, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
PCOS

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Nicotinic Acids
Niacin
Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014