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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Aliskiren; Drug: Telmisartan; Drug: Placebo to Aliskiren; Drug: Placebo to Telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00865020

CSPP100A2408

Details and patient eligibility

About

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.

Enrollment: 822 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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822 participants in 2 patient groups

Aliskiren 300 mg

Experimental group

Description:

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.

Treatment:

Drug: Aliskiren

Drug: Placebo to Aliskiren

Telmisartan 80 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo to Telmisartan

Drug: Telmisartan