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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

822 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aliskiren 300 mg

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.

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

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

Placebo to Aliskiren

Intervention Type DRUG

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

Telmisartan 80 mg

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.

Group Type ACTIVE_COMPARATOR

Telmisartan

Intervention Type DRUG

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

Placebo to Telmisartan

Intervention Type DRUG

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

Interventions

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Aliskiren

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

Intervention Type DRUG

Telmisartan

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

Intervention Type DRUG

Placebo to Aliskiren

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

Intervention Type DRUG

Placebo to Telmisartan

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mean sitting systolic blood pressure ≥ 140 mmHg and \< 180 mmHg
* 24-hr mean ambulatory systolic blood pressure ≥ 135 mmHg

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Novartis

Locations

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Investigative Site

Sorocaba, , Brazil

Site Status

Investigative Site

Gatineau, , Canada

Site Status

Investigative Site

Guayaquil, , Ecuador

Site Status

Investigative Site

Erfurt, , Germany

Site Status

Invesitagtive Site

Budapest, , Hungary

Site Status

Investigative Site

Kuala Lumpur, , Malaysia

Site Status

Investigative Site

Mexico City, , Mexico

Site Status

Investigative Site

Panama City, , Panama

Site Status

Investigative Site

Manila, , Philippines

Site Status

Investigative Site

Singapore, , Singapore

Site Status

Investigative Site

Bratislava, , Slovakia

Site Status

Investigative Site

Cheongju-si, , South Korea

Site Status

Investigative Site

Seville, , Spain

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Investigative Site

Istanbul, , Turkey (Türkiye)

Site Status

Investigative Site

Westbury, , United Kingdom

Site Status

Investigative Site

Caracas, , Venezuela

Site Status

Countries

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Brazil Canada Ecuador Germany Hungary Malaysia Mexico Panama Philippines Singapore Slovakia South Korea Spain Turkey (Türkiye) United Kingdom Venezuela