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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: Aliskiren 75 mg; Drug: Aliskiren 150 mg; Drug: Aliskiren 300 mg

• Study Type: Interventional
• Enrollment (Actual): 756
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Investigative Site
• Czech Republic
  • Prague, Czech Republic
    • Investigative Site
• Germany
  • Berlin, Germany
    • Investigative Site
• Iceland
  • Reykjavik, Iceland
    • Investigative Site
• Italy
  • Rome, Italy
    • Investigative Site
• Netherlands
  • Amsterdam, Netherlands
    • Investigative Site
• Poland
  • Warsaw, Poland
    • Investigative Site
• Slovakia
  • Bratislava, Slovakia
    • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo tablet taken once daily in the morning with a light meal.
Experimental: Aliskiren 75 mg	Drug: Aliskiren 75 mg; Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
Experimental: Aliskiren 150 mg	Drug: Aliskiren 150 mg; Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
Experimental: Aliskiren 300 mg	Drug: Aliskiren 300 mg; Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)	Baseline to end of study (Week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)		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.	Baseline to end of study (Week 8)
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.	Baseline to end of study (Week 8)
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.	Baseline to end of study (Week 8)
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.	Baseline to end of study (week 8)

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: June 25, 2008
• First Submitted That Met QC Criteria: June 26, 2008
• First Posted (Estimate): June 27, 2008

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 24, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Hypertension; placebo; aliskiren; ≥ 65 years; light meal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: CSPP100A2405