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 PeriodChange 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
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