Clinical trial NCT00865020: Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
ABPM
systolic blood pressure
diastolic blood pressure
cardiovascular disease
aliskiren
telmisartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 822
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 weeks, 13 weeks
Secondary outcomes:
measure: 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
timeFrame: 12 weeks, 13 weeks
measure: 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
timeFrame: Baseline, 13 weeks
measure: 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
timeFrame: Baseline, 12 weeks, 13 weeks
measure: 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
timeFrame: Baseline, 12 weeks, 13 weeks
Other outcomes:
Locations:
city: Sorocaba
country: Brazil
facility: Investigative Site
city: Gatineau
country: Canada
facility: Investigative Site
city: Guayaquil
country: Ecuador
facility: Investigative Site
city: Erfurt
country: Germany
facility: Investigative Site
city: Budapest
country: Hungary
facility: Invesitagtive Site
city: Cheongju
country: Korea, Republic of
facility: Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Investigative Site
city: Mexico City
country: Mexico
facility: Investigative Site
city: Panama City
country: Panama
facility: Investigative Site
city: Manila
country: Philippines
facility: Investigative Site
city: Singapore
country: Singapore
facility: Investigative Site
city: Bratislava
country: Slovakia
facility: Investigative Site
city: Sevilla
country: Spain
facility: Investigative Site
city: Istanbul
country: Turkey
facility: Investigative Site
city: Westbury
country: United Kingdom
facility: Investigative Site
city: Caracas
country: Venezuela
facility: Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Williams B, Lacy PS, Baschiera F, Brunel P, Dusing R. Novel description of the 24-hour circadian rhythms of brachial versus central aortic blood pressure and the impact of blood pressure treatment in a randomized controlled clinical trial: The Ambulatory Central Aortic Pressure (AmCAP) Study. Hypertension. 2013 Jun;61(6):1168-76. doi: 10.1161/HYPERTENSIONAHA.111.00763. Epub 2013 Apr 29.
citation: Dusing R, Brunel P, Baek I, Baschiera F. Sustained blood pressure-lowering effect of aliskiren compared with telmisartan after a single missed dose. J Clin Hypertens (Greenwich). 2013 Jan;15(1):41-7. doi: 10.1111/jch.12018. Epub 2012 Oct 9.