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Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension (AIMS)
This study is currently recruiting participants.
Verified by Novartis, November 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00797316
  Purpose

The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with HCTZ compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and < 200 mm Hg).


Condition Intervention Phase
Hypertension
Drug: Aliskiren plus Hydrochlorothiazide
Drug: Aliskiren
Phase IV

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Hydrochlorothiazide Aliskiren
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An 8-Week Randomized, Double-Blind, Parallel-Group, Multi-Center, Forced-Titration Study to Evaluate the Efficacy and Safety of Aliskiren Plus HCTZ Compared to Aliskiren Monotherapy in Metabolic Syndrome Patients With Stage 2 Hypertension

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in msSBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of aliskiren plus HCTZ versus aliskiren [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Reduction of msDBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Percent of responders with aliskiren plus HCTZ vs aliskiren [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving BP control after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in pulse pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 524
Study Start Date: November 2008
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Aliskiren plus Hydrochlorothiazide
Drug: Aliskiren plus Hydrochlorothiazide
Aliskiren plus HCTZ 150/12.5 mg: 1 week Aliskiren plus HCTZ 300/25 mg: 7 weeks
2: Active Comparator
Aliskiren 150mg: 1 week Aliskiren 300mg: 7 weeks
Drug: Aliskiren
Aliskiren 150mg: 1 week Aliskiren 300mg: 7 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
  • Male or female outpatients ≥ 18 years old.
  • Patients with stage 2 systolic hypertension. Patients must have a msSBP ≥160 mmHg and <200 mmHg at Study Visit 5 (randomization).
  • Patients who have stage 2 systolic hypertension that meet at least 2 additional components of the metabolic syndrome as defined by the National *Cholesterol Education program (NCEP) criteria:

    • Abdominal obesity (waist circumference > than 102 cm for men and > 88 cm for women)
    • Current triglycerides ≥ 150 mg/dL or medical treatment for this condition.
    • Current HDL- Cholesterol <40 mg/dL in men and <50 mg/dL in women or medical treatment for this condition.
    • Fasting glucose >100 mg/dL and <126 mg/dL

Exclusion Criteria:

  • Office blood pressure measured by cuff (msDBP ≥ 110 mmHg and or msSBP ≥ 200 mmHg) at any visit.
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
  • Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
  • History of hypersensitivity to any of the medications or to drugs belonging to a similar therapeutic class (diuretics or renin inhibitors) as the study drugs.
  • History or evidence of secondary form of hypertension.
  • Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
  • Patients on 4 or more antihypertensive medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797316

Contacts
Contact: Novartis 862-778-8300

Locations
United States, Illinois
Investigative Site Recruiting
North Chicago, Illinois, United States, 63110
Contact: Novartis     862-778-8300        
United States, Missouri
Investigative Site Recruiting
Springfield, Missouri, United States, 65807
Contact: Novartis     862-778-8300        
United States, New Jersey
Investigative Site Recruiting
Toms River, New Jersey, United States, 08753
Contact: Novartis     862-778-8300        
Investigative Site Recruiting
Margate City, New Jersey, United States, 08402
Contact: Novartis     862-778-8300        
United States, New York
Investigative Site Recruiting
Bronx, New York, United States, 10469
Contact: Novartis     862-778-8300        
United States, Pennsylvania
Investigative Site Recruiting
Morrisville, Pennsylvania, United States, 19067
Contact: Novartis     862-778-8300        
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CSPP100A2410
Study First Received: November 24, 2008
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00797316  
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension
Metabolic Syndrome
aliskiren
hydrochlorothiazide
systolic blood pressure
diastolic blood pressure
stage 2

Study placed in the following topic categories:
Vascular Diseases
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:
Disease
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Membrane Transport Modulators
Pathologic Processes
Natriuretic Agents
Therapeutic Uses
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009