An eight-week double-blind, multi-center, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren 75mg, 150mg and 300mg in elderly patients with essential hypertension when given a light meal

This study is an eight-week double-blind, multi-center, randomized,
placebo-controlled, paralel-group study to evaluate the efficacy and safety of
aliskiren 75mg, 150mg and 300mg in elderly patients with essential hypertension
when given with a light meal.

The primary objective of the study is to confirm the efficacy of aliskiren 75
mg, 150 mg and 300 mg in patients with essential hypertension by testing the
hypothesis of superior reduction in mean sitting systolic blood pressure
(msSBP) from baseline to study end when compared to placebo.
The secundary objectives are:
- Evaluate the efficacy of aliskiren 75 mg, 150 mg and 300 mg in patients with
essential hypertension by testing the hypothesis of superior reduction in mean
sitting diastolic blood pressure (msDBP) from baselineto study end when
compared to placebo.
- Evaluate the effect of aliskiren 75 mg, 150 mg and 300 mg and placebo on the
change from baseline in mean 24 hour ambulatory systolic blood pressure and
ambulatory diastolic blood pressure in a subset of patients.
- Evaluate the effect of aliskiren 75 mg, 150 mg, 300 mg and placebo on the
smoothness index, trough to peak ratio and morning surge of ambulatory systolic
blood pressure and ambulatory diastolic blood pressure in a subset of patients.
- Evaluate the proportion of patients achieving blood pressure response rate as
defined by msSBP < 140 mm Hg and/or a >/= 20 mm Hg decrease in msSBP from
baseline to end of study.
- Evaluate thye safety and tolerability of aliskiren 75 mg, 150 mg and 300 mg.

Patiënts should comply to the inclusion and exclusion criteria as stated in the
protocol. The study consists of a corestudy with a screening phase (wash-out
phase of one week), a single blinded phase (placebo phase of two or three
weeks) and a treatment phase (8 weeks of use of placebo, or aliskiren 75 mg,
150 mg or 300 mg).
Next to these study activities these patients will also be requested to
participate in the ABPM sub study (Ambulatory Blood Pressure Monitoring). In
this sub study patients will be requested to be hooked on the ABPM device one
day before visit 3 and visit 7. Blood pressure will the be measured for 24
hours and on Visit 3 and Visit 7 these devices will be unhooked. The total
study duration for each patient, inclusive of all phases, will be a minimum of
approximately 70 days.

Gedurende deze studie zullen de volgende parameters onderzocht worden:
Visite 1 (dag -21/-28): ICF; in-, exclusie criteria; medisch verleden;
lichamelijk onderzoek; bloeddruk; hartslag; stoppen/omlaag titratie
antihypertensie medicatie; rook verleden; labonderzoek; eventueel serum
zwangerschapstest; ander medicatiegebruik; screenings log; IVRS handelingen.
Visite 2 (dag -14/-21): in-, exclusie criteria; bloeddruk; hartslag; ander
medicatiegebruik; uitgeven studiemedicatie; IVRS handelingen.
Visite 201 (dag -7, zie protocol voor verdere specificaties van het nut van dit
bezoek): in-, exclusie criteria; bloeddruk; hartslag; adverse events; ander
medicatiegebruik; drug accountability; uitgeven studiemedicatie; IVRS
handelingen.
Visite 3 (dag -1 tot 1): in-, exclusie criteria; lichamelijk onderzoek;
lengte; gewicht; middelomvang; bloeddruk; hartslag; eventueel 24 uurs ABPM;
labonderzoek; adverse events; ander medicatiegebruik; drug accountability;
randomisatie; uitgeven studiemedicatie; IVRS handelingen.
Visite 4 (dag 14): bloeddruk; hartslag; labonderzoek; adverse events; ander
medicatiegebruik; drug accountability; uitgeven studiemedicatie; IVRS
handelingen.
Visite 5 en 6 (respectievelijk dag 28 en 42): bloeddruk; hartslag; adverse
events; ander medicatiegebruik; drug accountability; uitgeven studiemedicatie;
IVRS handelingen.
Visite 7 (dag 56 tot 57): lichamelijk onderzoek; gewicht; bloeddruk;
hartslag; eventueel 24 uurs ABPM; labonderzoek; adverse events; ander
medicatiegebruik; drug accountability; IVRS handelingen; einde studie gegevens.
During this study the following interventions will be conducted:
Visit 1 (day -21/-28): ICF; in-, exclusion criteria; medical history; physical
examination; blood pressure; pulse; discontinue/taper antihypertension
medication; smoking history; lab evaluations; if applicable serum pregnancy
test; concomitant medication; screenings log; IVRS.
Visit 2 (day -14/-21): in-, exclusion criteria; blood pressure; pulse;
concomitant medication; dispensing study medication; IVRS
Visit 201 (day -7, see protocol for further specifications for the purpose of
this visit): in-, exclusion criteria; blood pressure; pulse; adverse events;
concomitant medication; drug accountability; dispensing study medication; IVRS
Visit 3 (day -1 till 1): in-, exclusion criteria; physical examination; length;
weight; waistcircumference; blood pressure; pulse; if applicable 24 hour
measurements; lab evaluations; adverse events; discontinue/taper
antihypertension medication; drug accountability; randomization; concomitant
medication; dispensing study medication; IVRS.
Visit 4 (day 14): blood pressure; pulse; lab evaluations; adverse events;
concomitant medication; dispensing study medication; drug accountability; IVRS.
Visit 5 and 6 (respectively day 28 and 42): blood pressure; pulse; adverse
events; concomitant medication; drug accountability; dispensing study
medication; IVRS.
Visit 7 (day 56 till 57): physical examination; weight; blood pressure;
pulse; if applicable 24 hour measurements; lab evaluations; adverse events;
concomitant medication; drug accountability; IVRS; end of study information.

Potential inconveniences by participating in this trial might be that the
patient needs to visit the general practitioner for 6 to 8 times and that
his/her pulse/blood pressure will be measured 6 times. Also there will be a
toital of 4 visits where a total maximum of 40 ml blood will be withdrawn. In
case of blood samples taking there is a risk of some inconvenience and/or
bruises and seldom an inflammation occurs.