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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Aliskiren (Drug); Telmisartan (Drug); Placebo to Aliskiren (Drug); Placebo to Telmisartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

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

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.

Clinical Details

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 Acronym: ASSERTIVE - AliSkiren Study of Profound antihypERtensive Efficacy in hyperTensIVE Patients

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

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

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

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

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

Eligibility

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

Locations and Contacts

Investigative Site, Sorocaba, Brazil

Investigative Site, Gatineau, Canada

Investigative Site, Guayaquil, Ecuador

Investigative Site, Erfurt, Germany

Invesitagtive Site, Budapest, Hungary

Investigative Site, Cheongju, Korea, Republic of

Investigative Site, Kuala Lumpur, Malaysia

Investigative Site, Mexico City, Mexico

Investigative Site, Panama City, Panama

Investigative Site, Manila, Philippines

Investigative Site, Singapore, Singapore

Investigative Site, Bratislava, Slovakia

Investigative Site, Sevilla, Spain

Investigative Site, Istanbul, Turkey

Investigative Site, Westbury, United Kingdom

Investigative Site, Caracas, Venezuela

Additional Information

Starting date: March 2009
Last updated: June 22, 2011

Page last updated: August 23, 2015

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