Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00819767

Purpose

This study will compare the blunting effect of aliskiren and valsartan monotherapies on exercise-induced rises in SBP in patients with mild to moderate essential hypertension.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren Drug: Valsartan	Phase II

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure

Drug Information available for: Valsartan Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	An Eight-Week, Randomized, Double-Blind, Parallel-Group, Pilot Study to Evaluate the Efficacy and Safety of Aliskiren 300 mg in Comparison With Valsartan 320 mg in Patients With Mild to Moderate Hypertension During Exercise After a Missed Dose

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in systolic blood pressure at peak exercise (85% of the maximal predicted heart rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in systolic blood pressure at peak exercise (85% of the maximal predicted heart rate) from baseline to end of active treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change in systolic blood pressure during the treadmill exercise test assessed at each of the stages of the Bruce Protocol comparing: 1) study baseline to the end of active treatment; 2) study baseline and the end of active treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Overall safety and tolerability of aliskiren 300 mg compared to valsartan 320 mg monotherapies [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren 300mg	Drug: Aliskiren Aliskiren 300mg
2: Active Comparator Valsartan 320mg	Drug: Valsartan Valsartan 320mg

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg measured at rest
Patients being able to exercise and to reach 85% of their predicted heart rate during an exercise test on a treadmill

Exclusion Criteria:

Patients not confident in exercising or not able to exercise
Mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood pressure ≥ 110 mmHg measured at rest
Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819767

Contacts

Contact: Novartis

862-778-8300

Locations

China
Investigative Site
Singapore, China
Czech Republic
Investigative Site
Prague, Czech Republic
Investigative Site
,Pardubice, Czech Republic
Hungary
Investigative Site
Budapest, Hungary
Investigative Site
Szentendre, Hungary
United Kingdom
Investigative Site
Leicester, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSPP100A2406
Study First Received:	January 7, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819767
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Singapore: Health Sciences Authority

Keywords provided by Novartis:

Hypertension
systolic blood pressure
exercise test

cardiovascular disease
aliskiren
valsartan

Study placed in the following topic categories:

Vascular Diseases
Valsartan
Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009