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

Condition(s) targeted: Hypertension

Intervention: Aliskiren (Drug); Telmisartan (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

Overall contact:
Novartis, Phone: 862-778-8300

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 is 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 interruption.

Official title: A Twelve-week, Randomized, Double-blind, Parallel Group Study to Evaluate the Prolonged Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg in Mild to Moderate Hypertensive Patients With the 24-hour Ambulatory Blood Pressure Measurement After 1 Week of Treatment Withdrawal

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Primary outcome: Change in 24-hr mean ambulatory systolic blood pressure (MASBP) from the end of the active treatment period to day 7 of the treatment interruption period

Secondary outcome:

Change in 24-hr mean ambulatory diastolic blood pressure (MADBP) from the end of the active treatment period to day 7 of the treatment interruption period

Change in 24-hr MASBP and MADBP from baseline to day 7 of the treatment interruption period

Change in MASBP and MADBP as measured in the last 4 hours of the 24-hr-ABPM from a) the end of the active treatment period; b) baseline - to day 7 of the treatment interruption period (morning surge)

Change in MASBP and MADBP as measured in the last 4 hours of the 24-hr-ABPM from baseline to the end of the active treatment period (morning surge)

Change in msSBP and msDBP as measured at all study visits during the double-blind treatment period and during the treatment interruption period

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Novartis, Phone: 862-778-8300

Investigative Site, Sorocaba, Brazil; Not yet recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Gatineau, Canada; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Guayaquil, Ecuador; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Erfurt, Germany; Recruiting
Novartis, Phone: 862-778-8300

Invesitagtive Site, Budapest, Hungary; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Cheongju, Korea, Republic of; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Kuala Lumpur, Malaysia; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Mexico City, Mexico; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Panama City, Panama; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Manila, Philippines; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Singapore, Singapore; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Bratislava, Slovakia; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Sevilla, Spain; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Istanbul, Turkey; Not yet recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Westbury, United Kingdom; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Caracas, Venezuela; Not yet recruiting
Novartis, Phone: 862-778-8300

Starting date: March 2009
Last updated: September 11, 2009