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

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aliskiren

Hydrochlorothiazide

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Metabolic Syndrome, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, stage 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Novartis Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aliskiren plus Hydrochlorothiazide

Aliskiren

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)

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.

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.

Change From Baseline to Week 8 in Pulse Pressure

Full Information

NCT ID

NCT00797316

First Posted

November 24, 2008

Last Updated

March 8, 2011

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00797316

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

532 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aliskiren plus Hydrochlorothiazide

Arm Type

Experimental

Arm Description

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.

Arm Title

Aliskiren

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aliskiren

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Hydrochlorothiazide

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline and Week 8

Secondary Outcome Measure Information:

Title

Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)

Time Frame

8 weeks

Title

Percentage of Participants With Blood Pressure Response at Week 8

Description

Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.

Time Frame

8 weeks

Title

Percentage of Patients Achieving Blood Pressure Control at Week 8

Description

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.

Time Frame

8 weeks

Title

Change From Baseline to Week 8 in Pulse Pressure

Time Frame

Baseline and Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Pharmaceuticals

City

East Hanover

State/Province

New Jersey

ZIP/Postal Code

07936

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.bloodpressureresearch.com

Description

Related Info

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

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