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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00819767
First received: January 7, 2009
Last updated: June 2, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: Aliskiren
Drug: Valsartan
Drug: Placebo to aliskiren
Drug: Placebo to valsartan
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 68
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
 Drug: Aliskiren
Aliskiren was supplied in 150 mg tablets.
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.
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).
 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.

  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 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.

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

Locations
Czech Republic
Investigative Site
Pardubice, Czech Republic
Investigative Site
Prague, Czech Republic
Hungary
Investigative Site
Budapest, Hungary
Investigative Site
Nyiregyhaza, Hungary
Investigative Site
Pilisvörösvár, Hungary
Investigative Site
Szentendre, Hungary
Singapore
Investigative Site
Singapore, Singapore
United Kingdom
Investigative Site
Leicester, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00819767     History of Changes
Other Study ID Numbers: CSPP100A2406
Study First Received: January 7, 2009
Results First Received: December 7, 2010
Last Updated: June 2, 2011
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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013