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Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension (AIMS)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00797316
First received: November 24, 2008
Last updated: March 8, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (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
Drug: Hydrochlorothiazide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With Blood Pressure Response at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.

  • Percentage of Patients Achieving Blood Pressure Control at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Blood pressure control is defined as a patient who achieves a target Blood Pressure of mean sitting Systolic Blood Pressure / mean sitting Diastolic Blood pressure < 140/90 mmHg.

  • Change From Baseline to Week 8 in Pulse Pressure [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]

Enrollment: 532
Study Start Date: November 2008
Estimated Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren plus Hydrochlorothiazide
Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
 Drug: Aliskiren
Aliskiren 150 mg or 300 mg taken once daily in oral form
Drug: Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.
Active Comparator: Aliskiren
Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
 Drug: Aliskiren
Aliskiren 150 mg or 300 mg taken once daily in oral form

  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

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00797316     History of Changes
Other Study ID Numbers: CSPP100A2410
Study First Received: November 24, 2008
Results First Received: December 14, 2010
Last Updated: March 8, 2011
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

Additional relevant MeSH terms:
Hypertension
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hydrochlorothiazide
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

ClinicalTrials.gov processed this record on May 22, 2013