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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren; Drug: Hydrochlorothiazide

• Registration Number: NCT00797316
• Lead Sponsor: Novartis

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-12-14
• Results First Submitted QC: 2010-12-14
• Results First Posted: 2011-01-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-08
• Last Update Posted: 2011-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 532

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren plus Hydrochlorothiazide	Aliskiren	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.
Aliskiren	Aliskiren	Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Aliskiren plus Hydrochlorothiazide	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)	Baseline and Week 8

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)	8 weeks
Percentage of Participants With Blood Pressure Response at Week 8	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.
Percentage of Patients Achieving Blood Pressure Control at Week 8	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.
Change From Baseline to Week 8 in Pulse Pressure	Baseline and Week 8

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States