Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension.

Condition(s) targeted: Essential Hypertension

Intervention: Aliskiren (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis

The purpose of this study is to investigate the efficacy (blood pressure lowering effect) and safety of aliskiren given to hypertensive patients after a missed dose.

Official title: A Nine-Week, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren 300 mg Compared to Irbesartan 300 mg and Ramipril 10 mg in the Setting of a Missed Dose in Patients With Essential Hypertension

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, aliskiren 300 mg versus irbesartan 300mg.

from baseline.

Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, ramipril 10 mg versus irbesartan 300mg.

Secondary outcome:

efficacy on mean 24 hour ambulatory systolic blood pressure (MASBP) change

from baseline following a missed dose

efficacy on daytime and nighttime MASBP and MADBP change from baseline following a missed dose

efficacy on the MASBP and MADBP change from baseline following the last active dose prior to introducing a missed dose in any treatment group.

efficacy on the daytime and nighttime MASBP and MADBP change from baseline, following the last active dose prior to introducing a missed dose in any treatment group.

safety and tolerability

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatients 18 years of age and older.

- Patients must meet following blood pressure criteria:

At Visit 2 : Office Mean Sitting Diastolic Blood Pressure ≥ 90 mmHg and < 110 mmHg At Visit 3 : Office Mean Sitting Diastolic Blood Pressure ≥ 95 mmHg and < 110 mmHg before application of Ambulatory Blood Pressure Measurement device At Visit 3 : 24-hr Mean Ambulatory Diastolic Blood Pressure ≥ 85 mmHg

- Patient must have an absolute difference of ≤ 10 mmHg in their office Mean Sitting

Diastolic Blood Pressure between Visit 2 and 3.

- Male or female patients are eligible. Female patients must be either post-menopausal

for at least one year, surgically sterile or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.

- Patients who are eligible and able to participate in the study, and who consent to do

so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

Exclusion Criteria:

- Severe hypertension [Office Mean Sitting Diastolic Blood Pressure ≥ 110 mmHg and/or

office mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg].

- Current diagnosis of heart failure (NYHA Class II-IV).

- History of myocardial infarction, coronary bypass surgery, or any percutaneous

coronary intervention (PCI) during the 12 months prior to Visit 1.

- Known or suspected contraindications to the study medications, including history of

allergy to ACE-Inhibitors or ARBs.

- Upper arm circumference > 42 cm.

- Third shift or night workers.

Other protocol-defined inclusion/exclusion criteria may apply

Investigative Centers, Germany

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: May 2006
Last updated: January 9, 2008