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

NCT00819767 | Completed Phase 2 Results

• 1 other identifier: CSPP100A2406
• Study Type: interventional
• Target: 68
• Locations: 4 countries
• Sites: 8

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.

Conditions

Hypertension

Keywords

hypertension; systolic blood pressure; exercise test; cardiovascular disease; aliskiren; valsartan

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8

  Baseline and Week 8 (end of active treatment). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.

• 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

  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.

Study Arms (2)

Aliskiren

EXPERIMENTAL

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; Drug: Placebo to aliskiren; Drug: Placebo to valsartan

Valsartan

ACTIVE COMPARATOR

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; Drug: Placebo to aliskiren; Drug: Placebo to valsartan

Interventions

Aliskiren DRUG

Aliskiren was supplied in 150 mg tablets.

Aliskiren

Valsartan DRUG

Valsartan was supplied in 160 mg capsules.

Valsartan

Placebo to aliskiren DRUG

Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg.

Aliskiren; Valsartan

Placebo to valsartan DRUG

Placebo to valsartan was supplied in capsules matching valsartan 160 mg.

Aliskiren; Valsartan

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (8)

Investigative Site

Pardubice, Czechia

Location

Investigative Site

Prague, Czechia

Location

Investigative Site

Budapest, Hungary

Location

Investigative Site

Nyíregyháza, Hungary

Location

Investigative Site

Pilisvörösvár, Hungary

Location

Investigative Site

Szentendre, Hungary

Location

Investigative Site

Singapore, Singapore

Location

Investigative Site

Leicester, United Kingdom

Location

Related Publications (1)

• Wang GM, Li LJ, Fan L, Xu M, Tang WL, Wright JM. Renin inhibitors versus angiotensin receptor blockers for primary hypertension. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD012570. doi: 10.1002/14651858.CD012570.pub2.

  PMID: 40013543 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

aliskiren; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 9, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 28, 2011
• Results First Posted: June 28, 2011

Record last verified: 2011-06

Locations

CZ (2); SG (1); HU (4); GB (1)