NCT01293162: ARMOPREVCVR

Study on the Role of a Combination of Nutraceuticals (Armolipid Prev) With an Effect on Blood Pressure and Lipids in the Control of Cardiovascular Risk

Completed Last updated 2 February 2016

What this trial tests

trial testing Armolipid Prev in Metabolic Syndrome in 150 participants. Completed in 1 October 2014.

Timeline

1 September 2010

Primary endpoint
1 October 2014

1 October 2014

Quick facts

Lead sponsor	Federico II University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	1 September 2010
Primary completion	1 October 2014
Estimated completion	1 October 2014
Sites	1 location across Italy

Drugs / interventions tested

• Armolipid Prev — full drug profile →

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Federico II University

Who can join

Adults 18 to 75, any sex, with Metabolic Syndrome. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Cardiovascular risk
  Time frame: 12 months
  Reduction the global cardiovascular risk calculated according to Framingham risk score compared to baseline. Reduction of incident metabolic syndrome defined according to ATPIII criteria compared to baseline. Reduction of the prevalence of microalbuminuria evaluated by standard methods compared to baseline. Reduction of the prevalence of left ventricular hypertrophy evaluated by the ECG using t

Sponsor's own description

Cardiovascular risk has been shown to increase with increasing blood pressure values. As a consequence, it results mandatory to achieve lower blood pressure goals in all hypertensive patients, taking into account that all drugs always have some side effects that can be very dangerous and/or uncomfortable for the patients leading to a reduced compliance. Thus, pharmacological treatment should be delayed until it results really necessary.

The availability of natural substances with a therapeutic action has modified this scenario because of their reduced potential to cause undesirable effects (compared with drugs). In order to choose among various nutraceuticals (natural foods compounds with health benefits, including the prevention and/or treatment of diseases), preference should be given to those

* produced according to the same Good Manufacturing Practice used for drugs, to be sure that the finished product has a standard, reproducible composition
* for which efficacy and safety in the recommended indications are supported by clinical trials.

An example of a product with these characteristics is Armolipid Plus, a combination of nutraceuticals with a demonstrated anti-dyslipidaemic effect. Recently, a large clinical intervention study showed evidence that treatment with Armolipid Plus leads to a significant decrease in the overall cardiovascular risk, measured using the Framingham Risk Score.

Progress in Research and Development in this field has led to a new patented and registered combination of nutraceuticals: Armolipid Prev, containing orthosiphon and CoQ10, with antihypertensive activity, berberine, red yeast, policosanol and orthosiphon with antidyslipidaemic effect and folic acid, reducing plasma homocysteine levels.

In addition to the established anti-dyslipidaemic activity of Armolipid plus, Armolipid Prev has a significant antihypertensive effect, which is beneficial in all those patients with high blood pressure values without a defined indication to begin a pharmacological treatment according to the current guidelines. The antihypertensive effect of Armolipid Prev, documented by ambulatory blood pressure monitoring, in addition to the lowering effect on dyslipidaemia and even on abdominal girth, represents a new opportunity for complete and early, effective and safe cardiovascular disease prevention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.