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”

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

Study Type: Interventional

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

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Drug: aliskiren /amlodipine/hydrochlorothiazide
  • 1x aliskiren/amlodipine/hydrochlorothiazide

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • aliskiren 300/mg + amlodipine 10 mg + hydrochlorothiazide

Primary Measures

• 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.
  • Time Frame: 28 weeks
    Safety Issue?: Yes

Secondary Measures

• To assess the long-term blood pressure lowering (msDBP and msSBP) efficacy of the combination of aliskiren / amlodipine / hydrochlorothiazide in patients with essential hypertension
  • Time Frame: 0
    Safety Issue?: No
• To evaluate the proportion of patients achieving the blood pressure control target of < 140/90 mmHg at the end of the study.
  • Time Frame: 0
    Safety Issue?: No
• 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.
  • Time Frame: 0
    Safety Issue?: No

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair Novartis  

Overall Contact: Novartis 862-778-8300 

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00667719

Study ID Number: CSAH100A2301

ClinicalTrials.gov Identifier: NCT00667719

Health Authority: United States: Food and Drug Administration