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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706134
• Other study ID #: CSPP100A2405
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2008
• Last updated: June 24, 2011
• Start date: May 2008
• Est. completion date: April 2009

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: National Institute of HealthNetherlands: Medicines Evaluation Board (MEB)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 756
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Placebo
Placebo tablet taken once daily in the morning with a light meal.
• Aliskiren 75 mg
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
• Aliskiren 150 mg
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
• Aliskiren 300 mg
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

Locations

Country	Name	City	State
Argentina	Investigative Site	Buenos Aires
Czech Republic	Investigative Site	Prague
Germany	Investigative Site	Berlin
Iceland	Investigative Site	Reykjavik
Italy	Investigative Site	Rome
Netherlands	Investigative Site	Amsterdam
Poland	Investigative Site	Warsaw
Slovakia	Investigative Site	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Argentina,  Czech Republic,  Germany,  Iceland,  Italy,  Netherlands,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)		Baseline to end of study (Week 8)	No
Secondary	Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)		Baseline to end of study (Week 8)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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 (dh) and standard deviation (std dh) of the hourly changes were computed, and the SI was derived: SI = dh/std dh. A negative change score indicates improvement.	Baseline to end of study (Week 8)	No
Secondary	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)	No