Extension 1 to Protocol
A 2 year extension to a 36-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarction patients when added to optimized standard therapy

Protocol CSPP1200A2340 is a 36 week long clinical trial designed to provide
surrogate marker data [change in left ventricular end systolic volume (LVESV)
as determined by echocardiography] for the efficacy and safety of aliskiren
compared to placebo, when given in addition to optimized standard therapy in
high-risk post-Acute Myocardial Infarction (AMI) patients. Protocol
CSPP100A2340 is being extended by 2 years to obtain additional long-term safety
data in this high-risk post-AMI patient population as part of a post-marketing
commitment to the EMEA.

The primary objective of this 2 year extension study (CSPP100A2340E1) is to
provide additional long-term safety data in this patient population as a post
marketing commitment to the EMEA.

A secondary objective is to provide additional follow-up data on the effect of
aliskiren on left ventricular remodeling as measured by echocardiography - left
ventricular end systolic volume (LVESV), left ventricular end diastolic volume
(LVEDV), and left ventricular ejection fraction (LVEF).

Those patients that complete the original CSPP100A2340 *Core* study will be
offered continued participation in an additional 2 year safety extension to the
protocol. Those patients that agree to participate and sign a new Informed
Consent Form, will be prescribed aliskiren, 150 mg OD for two weeks. Patients
will then be up-titrated to 300 mg OD at the discretion of the principle
investigator, based on the patients clinical condition, for the duration of the
study (24 months/ 10 visits). In addition to their standard background
therapies. These patients will be evaluated for long-term safety. Visit 1
must occur on or within 5 days after Visit 10 of the CSPP100A2340 *Core* study.

At the completion of the *Core* study (Visit 10) all eligible patients that
agree to continue in the open-label safety extension and sign the Informed
Consent Form will be prescribed aliskiren, 150 mg OD for two weeks. Patients
will then be up-titrated to 300 mg OD at the discretion of the principle
investigator, based on the patients clinical condition, for the duration of the
study.

Risks are possible side effects of study medicine or another medicine, and
those of taking blood. The most common side effects reported in research
studies to date with aliskiren were:
* Headache
* Dizziness
* Fatigue
* Abdominal pain
* Nausea
* Diarrhea
Problems or side effects that are not now known could also occur.

10 study visits will be payed to the medical center. The tests done at each
study visit are standard medical tests. The most unpleasant is often having
blood samples taken, which will be done every visit. The risks of taking blood
may include pain and/or bruising.

The blood pressure cuff may also cause discomfort or bruising to the upper arm.
Bloodpressure will be taken every visit. Physical examinations (3 times),
electrocardiograms (ECGs; 3 times) and echocardiograms (ECHO; 2 times) are
routine procedures in clinical practice and present practically no risk to the
patient.