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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

November 24, 2008
March 8, 2011
November 2008
December 2009   (final data collection date for primary outcome measure)
Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Change from baseline in msSBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00797316 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension
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

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • 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.
  • 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.
    Interventions:
    • Drug: Aliskiren
    • Drug: Hydrochlorothiazide
  • Active Comparator: Aliskiren
    Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
    Intervention: Drug: Aliskiren
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
532
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00797316
CSPP100A2410
No
External Affairs, Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP