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Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Aliskiren 75 mg

Aliskiren 150 mg

Aliskiren 300 mg

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, ≥ 65 years, aliskiren, placebo, light meal

Eligibility Criteria

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

Inclusion Criteria:

Male and female outpatients 65 years of age and older.
Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Exclusion Criteria:

Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
History or evidence of a secondary form of hypertension.
Known Keith-Wagener grade III or IV hypertensive retinopathy.
History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
Current diagnosis of heart failure (NYHA Class II-IV).
History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
Current angina pectoris requiring pharmacological therapy other than nitrates.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Aliskiren 75 mg

Aliskiren 150 mg

Aliskiren 300 mg

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Percentage of Patients Achieving Systolic Blood Pressure Response

Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.

Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study

Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.

Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)

Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.

Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)

The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.

Full Information

NCT ID

NCT00706134

First Posted

June 25, 2008

Last Updated

June 24, 2011

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00706134

Brief Title

Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study

Official Title

An Eight-week Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.

6. Conditions and Keywords

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

Hypertension

Keywords

Hypertension, ≥ 65 years, aliskiren, placebo, light meal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

756 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Aliskiren 75 mg

Arm Type

Experimental

Arm Title

Aliskiren 150 mg

Arm Type

Experimental

Arm Title

Aliskiren 300 mg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet taken once daily in the morning with a light meal.

Intervention Type

Drug

Intervention Name(s)

Aliskiren 75 mg

Intervention Description

Aliskiren 75 mg tablet taken once daily in the morning with a light meal.

Intervention Type

Drug

Intervention Name(s)

Aliskiren 150 mg

Intervention Description

Aliskiren 150 mg tablet taken once daily in the morning with a light meal.

Intervention Type

Drug

Intervention Name(s)

Aliskiren 300 mg

Intervention Description

Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

Primary Outcome Measure Information:

Title

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

Time Frame