A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension

Condition(s) targeted: Essential Hypertension

Intervention: aliskiren /amlodipine/hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis

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

Overall contact:
Novartis, Phone: 862-778-8300

This study will test the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in patients with essential hypertension

Official title: A 28 to 54-Week, Open-Label, Multicenter Study to Assess the Long-Term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: To assess the long term safety of the combination of aliskiren /amlodipine / hydrochlorothiazide in patients with essential hypertension over 28 weeks to 54 weeks of treatment.

Secondary outcome:

To assess the long-term blood pressure lowering (msDBP and msSBP) efficacy of the combination of aliskiren / amlodipine / hydrochlorothiazide in patients with essential hypertension

To evaluate the proportion of patients achieving the blood pressure control target of < 140/90 mmHg at the end of the study.

To evaluate the proportion of patients achieving a response in mean sitting diastolic blood pressure (msDBP < 90 mmHg or a ≥ 10 mmHg decrease from baseline) and mean sitting systolic blood pressure (msSBP < 140 mmHg or a ≥ 20 mmHg decrease from baseline.

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

Criteria:

Inclusion Criteria:

- Outpatients 18 years of age or older

- Male or female patients are eligible.

- msDBP & msSBP Requirements:

- For newly diagnosed/untreated patients, msDBP ≥ 100 and < 120 mmHg, and/or msSBP

≥ 160 and < 200 mmHg at Visit 1 and Visit 2.

- For previously treated patients, msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160

and < 200 mmHg at Visit 2, Visit 3, or Visit 4.

- For patients requiring tapering off their previous antihypertensive medication, they

must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase of the study.

- 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:

- Inability to discontinue all prior antihypertensive medications safely for a period of

1 week to 4 weeks as required by the protocol.

- Patients on three antihypertensive drugs with msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg

at Visit 1.

- Patients on four or more antihypertensive drugs at Visit 1.

- Patients with an msSBP ≥ 200 and msDBP ≥ 120 mmHg anytime during the washout period of

the study Visit 1-4 must be discontinued from the study.

- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a

female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>= 5 mIU/mL).

Novartis, Phone: 862-778-8300

Investigative Site, Belgium, Belgium; Not yet recruiting
Phone: 41 61 324 1111

Investigative Site, Egypt, Egypt; Not yet recruiting
Novartis, Phone: 41 61 324 1111

Investigative Site, Germany, Germany; Not yet recruiting
Novartis, Phone: 41 61 324 1111

Investigative Site, Poland, Poland; Not yet recruiting
Novartis, Phone: 41 61 324 1111

Investigative Site, Slovakia, Slovakia; Not yet recruiting
Novartis, Phone: 41 61 324 1111

Investigative Site, Spain, Spain; Not yet recruiting
Novartis, Phone: 41 61 324 1111

Investigative Site, Turkey, Turkey; Not yet recruiting
Novartis, Phone: 41 61 324 1111

Investigative Site, Houston, Texas, United States; Recruiting
Novartis, Phone: 862-778-8300

Starting date: June 2008
Last updated: June 12, 2008