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

NCT ID: NCT00797316

Last Updated: 2011-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-12-31

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).

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Aliskiren

Intervention Type: DRUG

Aliskiren 150 mg or 300 mg taken once daily in oral form

Hydrochlorothiazide

Intervention Type: DRUG

Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.

Aliskiren

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

Group Type: ACTIVE_COMPARATOR

Aliskiren

Intervention Type: DRUG

Aliskiren 150 mg or 300 mg taken once daily in oral form

Interventions

Aliskiren

Aliskiren 150 mg or 300 mg taken once daily in oral form

Intervention Type: DRUG

Hydrochlorothiazide

Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CSPP100A2410

Identifier Type: -

Identifier Source: org_study_id