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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00667719
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will test the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in patients with essential hypertension

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: aliskiren /amlodipine/hydrochlorothiazide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2008
Primary Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
aliskiren 300/mg + amlodipine 10 mg + hydrochlorothiazide
Drug: aliskiren /amlodipine/hydrochlorothiazide
1x aliskiren/amlodipine/hydrochlorothiazide


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00667719     History of Changes
Other Study ID Numbers: CSAH100A2301
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2012

Keywords provided by Novartis:
essential hypertension
high blood pressure

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