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

NCT00797316 | Completed Phase 4 Results

• 1 other identifier: CSPP100A2410
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)

  Baseline and Week 8

Secondary Outcomes (4)

• 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

• Percentage of Patients Achieving Blood Pressure Control at Week 8

  8 weeks

• Change From Baseline to Week 8 in Pulse Pressure

  Baseline and Week 8

Study Arms (2)

Aliskiren plus Hydrochlorothiazide

EXPERIMENTAL

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; Drug: Hydrochlorothiazide

Aliskiren

ACTIVE COMPARATOR

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

Drug: Aliskiren

Interventions

Aliskiren DRUG

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

Aliskiren; Aliskiren plus Hydrochlorothiazide

Hydrochlorothiazide DRUG

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

Aliskiren plus Hydrochlorothiazide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Hypertension; Metabolic Syndrome

Interventions

aliskiren; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 11, 2011
• Results First Posted: January 12, 2011

Record last verified: 2011-03

Locations

US (1)