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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00706134

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren Drug: Placebo Drug: Aliskiren 150 mg Drug: Aliskiren 300 mg	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Eight-Week Study to Evaluate the Efficacy and Safety of Aliskiren 75mg, 150mg and 300mg in Elderly Patients With Essential Hypertension When Given With a Light Meal

Further study details as provided by Novartis:

Primary Outcome Measures:

Reduction in mean sitting systolic blood pressure (msSBP) from baseline to study end comparing aliskiren 975, 150 and 300 mg to placebo [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in mean sitting diastolic blood pressure (msDBP) from baseline to study end comparing aliskiren (75, 150 and 300 mg)to placebo [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline in mean 24 hour ambulatory systolic blood pressure and ambulatory diastolic blood pressure in a subset of patients comparing aliskiren (75, 150 and 300 mg) to placebo [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in smoothness index, trough to peak ratio and morning surge of ambulatory systolic blood pressure and ambulatory diastolic blood pressure in a subset of patients comparing aliskiren (75, 150 and 300 mg) to placebo [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Proportion of patients achieving blood pressure response rate as defined by msSBP < 140 mmHg and/or a ≥ 20 mmHg decrease in msSBP from baseline to end of study in aliskiren (75, 150 and 300 mg) and placebo. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Safety and tolerability of aliskiren 75 mg, 150 mg and 300 mg [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	644
Study Start Date:	May 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren 75 mg	Drug: Aliskiren Aliskiren 75 mg
2: Placebo Comparator	Drug: Placebo Placebo
3: Experimental Aliskiren 150 mg	Drug: Aliskiren 150 mg Aliskiren 150 mg
4: Experimental Aliskiren 300 mg	Drug: Aliskiren 300 mg Aliskiren 300 mg

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706134

Contacts

Contact: Novartis

862-778-8300

Locations

Czech Republic
Investigative Site	Recruiting
Prague, Czech Republic
Contact: Novartis 862-778-8300
France
Investigative Site	Recruiting
Paris, France
Contact: Novartis 862-778-8300
Germany
Investigative Site	Recruiting
Berlin, Germany
Contact: Novartis 862-778-8300
Iceland
Investigative Site	Recruiting
Reykjavik, Iceland
Contact: Novartis 862-778-8300
Italy
Investigative Site	Recruiting
Rome, Italy
Contact: Novartis 862-778-8300
Netherlands
Investigative Site	Recruiting
Amsterdam, Netherlands
Contact: Novartis 862-778-8300
Poland
Investigative Site	Recruiting
Warsaw, Poland
Contact: Novartis 862-778-8300
Slovakia
Investigative Site	Recruiting
Bratislava, Slovakia
Contact: Novartis 862-778-8300

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CSPP100A2405
Study First Received:	June 25, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00706134
Health Authority:	Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: National Institute of Health; Netherlands: Medicines Evaluation Board (MEB); Poland: Drug Institute; Slovakia: State Institute for Drug Control

Keywords provided by Novartis:

Hypertension
≥ 65 years
aliskiren
placebo
light meal

Study placed in the following topic categories:

Vascular Diseases
Essential hypertension
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009