A phase III, double-blind, randomized, placebo-controlled, multi-center study evaluating the efficacy and safety of dalcetrapib on lipids, lipoproteins, apolipoproteins and markers of CV risk in patients hospitalized for an acute coronary syndrome (ACS) when treatment is initiated within 1 week after an ACS (dal-ACUTE).

In support of study NC20971, study WC25501 will provide evidence of efficacy
and safety of dalcetrapib when treatment is
started within 1 week after an ACS, by comparing the effect of dalcetrapib on
lipid profile when treatment is started within 1
week after an ACS (in this study) to treatment started 4 to 12 weeks after an
ACS (in study NC20971).

Study NC20971 is a phase III study evaluating the effects of dalcetrapib on
cardiovascular (CV) risk in stable CHD patients,
with a documented recent ACS in support of the indication *For the prevention
of CV mortality and morbidity in adult patients
with stable coronary heart disease (CHD) following a recent Acute Coronary
Syndrome (ACS) event, used in addition to
standard CV treatments (including lipid lowering strategies)*.

The primary objective of this study is to evaluate the effect of dalcetrapib on
HDL-C levels after 4 weeks of treatment when
treatment is initiated within 1 week after an ACS.

The secondary objectives of this study are:
- To compare the effect of dalcetrapib on HDL-C levels after 4 weeks of
treatment when treatment is initiated within 1 week after an ACS (in this
study) with dalcetrapib initiated 4 to 12 weeks after an ACS (in study NC20971)

- To evaluate the effect of dalcetrapib on HDL-C levels after 8, 12 and 20
weeks of treatment

- To evaluate the effect of dalcetrapib on lipids, lipoproteins, lipoprotein
sub-fractions, apolipoproteins, measures of HDL functionality, CETP mass and
CETP activity

- To evaluate the effect of dalcetrapib on markers of CV risk

- To evaluate the safety profile of dalcetrapib

This trial will be a double-blind, randomized, placebo-controlled, parallel
group, multi-center study in patients hospitalized for an
acute coronary syndrome (ACS).

Patients admitted to the hospital for an ACS event who provided written
informed consent will be screened for eligibility. The screening period should
be as short as possible and no longer than 1 week after the ACS event, in which
all pre-randomization assessments will be conducted.

Eligible patients will receive double-blind treatment with either 600 mg of
dalcetrapib or matching placebo for 20 weeks on a
background of contemporary, guidelines-based medical care for ACS. The
double-blind treatment period will be followed by a 4- week safety follow-up.

Visits are scheduled 4, 8, 12 and 20 weeks after randomization.

Patients will be subjected to the following interventions/precedures or define
behavioural rules:
- physical examination
- Height and weight is measured
- Blood pressure and Heart rate are measured
- all blood samples should be taken in the fasting state
- a quality of live questionnaire will be assesed at each visit
- counseling on heart healthy diet and lifestile will be given
- serum or urine prenancy test

So far, 526 healthy volunteers received single doses of up to 4500 mg or
multiple doses of up to 3900 mg of dalcetrapib. In addition, 1630 patients have
received doses of dalcetrapib of up to 900 mg for up to one year. Approximately
16,300 patients are currently participating in studies with dalcetrapib.


The most common side effect of the study drug in these previous studies was:
• Diarrhea and stool abnormalities (10-15%)

Other common (1-10%) side effects included:
• dizziness
• headache
• sleep disorders

Of all these side effects, only diarrhea is considered to be caused by
dalcetrapib.

Your study doctor or study staff will take your blood using a needle. Some
problems you might have from this are: pain, bruises, dizziness or infection at
the place of the puncture.

The development of a similar compound, called torcetrapib, was stopped in
December 2006. This was due to the fact that in a large long-term trial
including approximately 15,000 patients, there were more cardiovascular (49 in
the torcetrapib versus 35 in the control group) and non-cardiovascular (40
versus 20) deaths and generally an increased cardiovascular risk in people
taking torcetrapib compared to the group taking placebo. The non-cardiovascular
deaths were mostly due to cancer and infections.
Torcetrapib leads to increases in blood pressure, and increased levels of
aldosterone and cortisol. Aldosterone leads to increased blood pressure and in
addition has direct negative effects on blood vessels which may lead to
cardiovascular events. Cortisol is involved in the regulation of the immune
system and high levels of it lead to a down regulation of the system. A
down-regulated immune system may lead to an increase in infections and cancers.
No clinical benefit has been seen in patients who received torcetrapib versus
those who received placebo.
The study drug you will be taking, dalcetrapib, has a very different chemical
structure than torcetrapib. In agreement with this, many pre-clinical and
clinical experiments showed that dalcetrapib does not lead to increases in
blood pressure. Importantly, treatment with dalcetrapib does not lead to
increased levels of aldosterone and cortisol.

Blood levels for HDL-C (good cholesterol) may improve as a result of taking
dalcetrapib in this study. Data from clinical trials with other HDL increasing
compounds as well as data from animal studies, strongly suggest that increasing
HDL-C reduces future cardiovascular risk.
The close medical attention the patient gets during the study may result in
gaining new information about their health which may provide benefits for their
general health and well being. Nevertheless, it is possible, that the patient
will not get any benefit from participating in this study.