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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 7, 2009

Last Updated Date

April 20, 2009

Start Date ^†

January 2009

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00819767 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Condition ^†

Hypertension

Intervention ^†

Drug: Aliskiren
Drug: Valsartan

Study Arms / Comparison Groups

Experimental: Aliskiren 300mg
Active Comparator: Valsartan 320mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Completion Date

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis

862-778-8300

Location Countries ^†

China, Czech Republic, Hungary, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00819767

Responsible Party

External Affairs, Novartis Pharmaceuticals

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.