Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal

NCT00865020 | Completed Phase 4 Results

• 1 other identifier: CSPP100A2408
• Study Type: interventional
• Target: 822
• Locations: 16 countries
• Sites: 16

Brief Summary

This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood Pressure Monitoring setting after a one week treatment withdrawal.

Conditions

Hypertension

Keywords

Hypertension; ABPM; systolic blood pressure; diastolic blood pressure; cardiovascular disease; aliskiren; telmisartan

Outcome Measures

Primary Outcomes (1)

• Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period

  An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.

  12 weeks, 13 weeks

Secondary Outcomes (4)

• Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period

  12 weeks, 13 weeks

• Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period

  Baseline, 13 weeks

• Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period

  Baseline, 12 weeks, 13 weeks

• Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period

  Baseline, 12 weeks, 13 weeks

Study Arms (2)

Aliskiren 300 mg

EXPERIMENTAL

Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.

Drug: Aliskiren; Drug: Placebo to Aliskiren

Telmisartan 80 mg

ACTIVE COMPARATOR

Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.

Drug: Telmisartan; Drug: Placebo to Telmisartan

Interventions

Aliskiren DRUG

Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks.

Aliskiren 300 mg

Telmisartan DRUG

Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks.

Telmisartan 80 mg

Placebo to Aliskiren DRUG

Placebo to Aliskiren tablets taken orally daily. 1 Tablet for the first 2 weeks and 2 tablets during the no treatment (withdrawal) week.

Aliskiren 300 mg

Placebo to Telmisartan DRUG

Placebo to Telmisartan capsule taken orally daily. 1 capsule for the first 2 weeks and 2 capsules during the no treatment (withdrawal) week.

Telmisartan 80 mg

Eligibility Criteria

• Age: 18 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
• hr mean ambulatory systolic blood pressure ≥ 135 mmHg

You may not qualify if:

• Severe hypertension defined as mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood pressure ≥ 110 mmHg
• Patients with Type 1 diabetes mellitus
• Secondary hypertension of any etiology

Sponsors & Collaborators

• Novartis: lead

Study Sites (16)

Investigative Site

Sorocaba, Brazil

Location

Investigative Site

Gatineau, Canada

Location

Investigative Site

Guayaquil, Ecuador

Location

Investigative Site

Erfurt, Germany

Location

Invesitagtive Site

Budapest, Hungary

Location

Investigative Site

Kuala Lumpur, Malaysia

Location

Investigative Site

Mexico City, Mexico

Location

Investigative Site

Panama City, Panama

Location

Investigative Site

Manila, Philippines

Location

Investigative Site

Singapore, Singapore

Location

Investigative Site

Bratislava, Slovakia

Location

Investigative Site

Cheongju-si, South Korea

Location

Investigative Site

Seville, Spain

Location

Investigative Site

Istanbul, Turkey (Türkiye)

Location

Investigative Site

Westbury, United Kingdom

Location

Investigative Site

Caracas, Venezuela

Location

Related Publications (3)

• 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

• Williams B, Lacy PS, Baschiera F, Brunel P, Dusing R. Novel description of the 24-hour circadian rhythms of brachial versus central aortic blood pressure and the impact of blood pressure treatment in a randomized controlled clinical trial: The Ambulatory Central Aortic Pressure (AmCAP) Study. Hypertension. 2013 Jun;61(6):1168-76. doi: 10.1161/HYPERTENSIONAHA.111.00763. Epub 2013 Apr 29.

  PMID: 23630950 DERIVED

• Dusing R, Brunel P, Baek I, Baschiera F. Sustained blood pressure-lowering effect of aliskiren compared with telmisartan after a single missed dose. J Clin Hypertens (Greenwich). 2013 Jan;15(1):41-7. doi: 10.1111/jch.12018. Epub 2012 Oct 9.

  PMID: 23282123 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

aliskiren; Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 22, 2011
• Results First Posted: July 22, 2011

Record last verified: 2011-06

Locations

EC (1); TU (1); VE (1); ES (1); PA (1); SG (1); SL (1); PH (1); CA (1); MY (1); KR (1); HU (1); ME (1); DE (1); BR (1); GB (1)