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

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ClinicalTrials.gov Identifier: NCT00819767
Recruitment Status : Completed
First Posted : January 9, 2009
Results First Posted : June 28, 2011
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE January 7, 2009
First Posted Date  ICMJE January 9, 2009
Results First Submitted Date  ICMJE December 7, 2010
Results First Posted Date  ICMJE June 28, 2011
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose [ Time Frame: 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. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
Change from baseline in systolic blood pressure at peak exercise (85% of the maximal predicted heart rate) [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT00819767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
  • Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 [ Time Frame: Baseline and Week 8 (end of active treatment). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints. ]
    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.
  • 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 [ Time Frame: 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. ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
  • 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 ]
  • 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 ]
  • Overall safety and tolerability of aliskiren 300 mg compared to valsartan 320 mg monotherapies [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise
Official Title  ICMJE 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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Aliskiren
    Aliskiren was supplied in 150 mg tablets.
  • Drug: Valsartan
    Valsartan was supplied in 160 mg capsules.
  • Drug: Placebo to aliskiren
    Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg.
  • Drug: Placebo to valsartan
    Placebo to valsartan was supplied in capsules matching valsartan 160 mg.
Study Arms  ICMJE
  • Experimental: Aliskiren
    For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
    Interventions:
    • Drug: Aliskiren
    • Drug: Placebo to aliskiren
    • Drug: Placebo to valsartan
  • Active Comparator: Valsartan
    For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
    Interventions:
    • Drug: Valsartan
    • Drug: Placebo to aliskiren
    • Drug: Placebo to valsartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2009)
68
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2009)
60
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Hungary,   Singapore,   United Kingdom
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT00819767
Other Study ID Numbers  ICMJE CSPP100A2406
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis Pharmaceuticals
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Novartis
PRS Account Novartis
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP