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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00667719
First received: April 24, 2008
Last updated: November 30, 2012
Last verified: November 2012
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

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 ]

Enrollment: 564
Study Start Date: June 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00667719     History of Changes
Other Study ID Numbers: CSAH100A2301
Study First Received: April 24, 2008
Last Updated: November 30, 2012
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 Agency of Medicines
Turkey: Ministry of Health

Keywords provided by Novartis:
essential hypertension
high blood pressure

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

ClinicalTrials.gov processed this record on July 20, 2014