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

Hypertension Clinical Trial

— AIMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797316
• Other study ID #: CSPP100A2410
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2008
• Last updated: March 8, 2011
• Start date: November 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome X

Intervention

Drug:
• Aliskiren
Aliskiren 150 mg or 300 mg taken once daily in oral form
• Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)		Baseline and Week 8	No
Secondary	Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)		8 weeks	No
Secondary	Percentage of Participants With Blood Pressure Response at Week 8	Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline = 20 mmHg in msSBP during eight weeks of treatment.	8 weeks	No
Secondary	Percentage of Patients Achieving Blood Pressure Control at Week 8	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.	8 weeks	No
Secondary	Change From Baseline to Week 8 in Pulse Pressure		Baseline and Week 8	No

External Links

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