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A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension
This study has been completed.
First Received: April 24, 2008   Last Updated: October 23, 2009   History of Changes
Sponsor: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00667719
  Purpose

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


Condition Intervention Phase
Essential Hypertension
Drug: aliskiren /amlodipine/hydrochlorothiazide
Phase III

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment: 564
Study Start Date: June 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
aliskiren 300/mg + amlodipine 10 mg + hydrochlorothiazide
Drug: aliskiren /amlodipine/hydrochlorothiazide
1x aliskiren/amlodipine/hydrochlorothiazide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667719

Locations
United States, Texas
Investigative Site
Houston, Texas, United States
Belgium
Investigative Site
Belgium, Belgium
Egypt
Investigative Site
Egypt, Egypt
Germany
Investigative Site
Germany, Germany
Poland
Investigative Site
Poland, Poland
Slovakia
Investigative Site
Slovakia, Slovakia
Spain
Investigative Site
Spain, Spain
Turkey
Investigative Site
Turkey, Turkey
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis )
Study ID Numbers: CSAH100A2301
Study First Received: April 24, 2008
Last Updated: October 23, 2009
ClinicalTrials.gov Identifier: NCT00667719     History of Changes
Health Authority: United States: Food and Drug Administration;   Belgium: Pharmaceutical Inspectorate;   Germany: Federal Institute for Drugs and Medical Devices;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Slovakia: State Institute for Drug Control;   Spain: Spanish Drug Agency;   Turkey: Ministry of Health

Keywords provided by Novartis:
essential hypertension
high blood pressure

Additional relevant MeSH terms:
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010