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

Hypertension Clinical Trial

— ASSERTIVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00865020
• Other study ID #: CSPP100A2408
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2009
• Last updated: June 22, 2011
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthCanada: Health CanadaEcuador: Public Health MinistryGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyKorea: Food and Drug AdministrationMalaysia: Ministry of HealthMexico: Ministry of HealthPanama: Ministry of HealthPhilippines: Bureau of Food and DrugsSingapore: Health Sciences AuthoritySlovakia: State Institute for Drug ControlSpain: Spanish Agency of MedicinesTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyVenezuela: Ministry of Health and Social Development
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 822
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Aliskiren
Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks.
• Telmisartan
Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks.
• Placebo to Aliskiren
Placebo to Aliskiren tablets taken orally daily. 1 Tablet for the first 2 weeks and 2 tablets during the no treatment (withdrawal) week.
• Placebo to Telmisartan
Placebo to Telmisartan capsule taken orally daily. 1 capsule for the first 2 weeks and 2 capsules during the no treatment (withdrawal) week.

Locations

Country	Name	City	State
Brazil	Investigative Site	Sorocaba
Canada	Investigative Site	Gatineau
Ecuador	Investigative Site	Guayaquil
Germany	Investigative Site	Erfurt
Hungary	Invesitagtive Site	Budapest
Korea, Republic of	Investigative Site	Cheongju
Malaysia	Investigative Site	Kuala Lumpur
Mexico	Investigative Site	Mexico City
Panama	Investigative Site	Panama City
Philippines	Investigative Site	Manila
Singapore	Investigative Site	Singapore
Slovakia	Investigative Site	Bratislava
Spain	Investigative Site	Sevilla
Turkey	Investigative Site	Istanbul
United Kingdom	Investigative Site	Westbury
Venezuela	Investigative Site	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Brazil,  Canada,  Ecuador,  Germany,  Hungary,  Korea, Republic of,  Malaysia,  Mexico,  Panama,  Philippines,  Singapore,  Slovakia,  Spain,  Turkey,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.	12 weeks, 13 weeks	No
Secondary	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	An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MADBP was calculated by taking the mean of all Ambulatory Diastolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MADBP from the end of the active treatment to Day 7 of the withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.	12 weeks, 13 weeks	No
Secondary	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	An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at Baseline (at Randomization) and at week 13 (day 7 of the withdrawal period). The 4 Hour MASBP and MADBP was calculated by taking the mean of all Ambulatory Blood Pressure readings during the 24 hour period. The difference of the 24 hour measurements from baseline to day 7 of the withdrawal period were calculated using a two way analysis of variance with treatment and region as factors and baseline as a covariate.	Baseline, 13 weeks	No
Secondary	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	Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 minutes apart were used in the analysis.; The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msSBP as a covariate.; The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.	Baseline, 12 weeks, 13 weeks	No
Secondary	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	Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 min. apart were used in the analysis.; The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msDBP as a covariate.; The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.	Baseline, 12 weeks, 13 weeks	No