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

• ClinicalTrials.gov Identifier: NCT00797316
• Recruitment Status: Completed
• First Posted: November 25, 2008
• Results First Posted: January 12, 2011
• Last Update Posted: March 11, 2011
• Sponsor: Novartis
• Information provided by: Novartis

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hypertension	Drug: Aliskiren; Drug: Hydrochlorothiazide	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 532 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: November 2008
• Actual Primary Completion Date: December 2009
• Study Completion Date: December 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline and Week 8 ]

Secondary Outcome Measures :

1. Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: 8 weeks ]
2. Percentage of Participants With Blood Pressure Response at Week 8 [ Time Frame: 8 weeks ]
   Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.
3. Percentage of Patients Achieving Blood Pressure Control at Week 8 [ Time Frame: 8 weeks ]
   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.
4. Change From Baseline to Week 8 in Pulse Pressure [ Time Frame: Baseline and Week 8 ]

Eligibility Criteria

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

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 

• Responsible Party: External Affairs, Novartis
• ClinicalTrials.gov Identifier: NCT00797316
• Other Study ID Numbers: CSPP100A2410
• First Posted: November 25, 2008
• Results First Posted: January 12, 2011
• Last Update Posted: March 11, 2011
• Last Verified: March 2011

Keywords provided by Novartis:

Hypertension; Metabolic Syndrome; aliskiren; hydrochlorothiazide; systolic blood pressure; diastolic blood pressure; stage 2

Additional relevant MeSH terms:

Hypertension; Metabolic Syndrome; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Hydrochlorothiazide; Antihypertensive Agents; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sodium Chloride Symporter Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action