Expired Study
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Houston, Texas


Purpose:

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


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).


NCT ID:

NCT00667719


Primary Contact:

Study Chair
Novartis
Novartis


Backup Contact:

N/A


Location Contact:

Houston, Texas
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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