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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819767
• Other study ID #: CSPP100A2406
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2009
• Last updated: June 2, 2011
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacySingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

This study compared the blunting effect of aliskiren and valsartan monotherapies on exercise-induced rises in systolic blood pressure in patients with mild to moderate essential hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion criteria:

• Mean sitting systolic blood pressure = 140 mmHg and < 180 mmHg measured at rest

• Patients able to exercise and to reach 85% of their predicted heart rate during a standard exercise test on a treadmill according to the Bruce Protocol

Exclusion criteria:

• Patients not confident in exercising or not able to exercise

• Absolute contraindication 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 applied to the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Aliskiren
Aliskiren was supplied in 150 mg tablets.
• Valsartan
Valsartan was supplied in 160 mg capsules.
• Placebo to aliskiren
Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg.
• Placebo to valsartan
Placebo to valsartan was supplied in capsules matching valsartan 160 mg.

Locations

Country	Name	City	State
Czech Republic	Investigative Site	Pardubice
Czech Republic	Investigative Site	Prague
Hungary	Investigative Site	Budapest
Hungary	Investigative Site	Nyiregyhaza
Hungary	Investigative Site	Pilisvörösvár
Hungary	Investigative Site	Szentendre
Singapore	Investigative Site	Singapore
United Kingdom	Investigative Site	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Czech Republic,  Hungary,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose	The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 + 2 days (24-hrs after a missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.	Baseline and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.	No
Secondary	Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8	The difference in resting vs. peak (85% of the maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 (end of active treatment); the change in SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.	Baseline and Week 8 (end of active treatment). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.	No
Secondary	Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Week 8 (End of Active Treatment) to 24-hours After a Missed Dose	The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. The SBP at rest vs peak HR was recorded at Week 8 (end of active treatment) and Week 8 + 2 days (48-hrs after last dose; 24-hrs after missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.	Week 8 (Last dose; end of active treatment) and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.	No