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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00865020
First received: March 17, 2009
Last updated: June 22, 2011
Last verified: June 2011
Results First Received: June 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Aliskiren
Drug: Telmisartan
Drug: Placebo to Aliskiren
Drug: Placebo to Telmisartan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1359 participants entered the Placebo Run-In phase which was 1-2 weeks in duration. Those participants completing the Placebo-Run-In Phase were randomized to receive either aliskiren 300 mg or telmisartan 80 mg.

Reporting Groups
  Description
Aliskiren 300 mg Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
Telmisartan 80 mg Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.

Participant Flow:   Overall Study
    Aliskiren 300 mg     Telmisartan 80 mg  
STARTED     414     408  
COMPLETED     365     357  
NOT COMPLETED     49     51  
Withdrawal by Subject                 22                 16  
Adverse Event                 9                 14  
Abnormal test procedure result(s)                 6                 8  
Lost to Follow-up                 6                 4  
Protocol deviation                 4                 1  
Administrative problems                 0                 2  
Abnormal laboratory value(s)                 0                 1  
Death                 0                 1  
Randomized but discontinued                 2                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aliskiren 300 mg Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
Telmisartan 80 mg Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
Total Total of all reporting groups

Baseline Measures
    Aliskiren 300 mg     Telmisartan 80 mg     Total  
Number of Participants  
[units: participants]
  414     408     822  
Age  
[units: years]
Mean ± Standard Deviation
  55.8  ± 11.46     56.0  ± 11.91     55.9  ± 11.68  
Gender  
[units: participants]
     
Female     206     178     384  
Male     208     230     438  



  Outcome Measures
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1.  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   [ Time Frame: 12 weeks, 13 weeks ]

2.  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   [ Time Frame: 12 weeks, 13 weeks ]

3.  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   [ Time Frame: Baseline, 13 weeks ]

4.  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   [ Time Frame: Baseline, 12 weeks, 13 weeks ]

5.  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   [ Time Frame: Baseline, 12 weeks, 13 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00865020     History of Changes
Other Study ID Numbers: CSPP100A2408
Study First Received: March 17, 2009
Results First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: Brazil: Ministry of Health
Canada: Health Canada
Ecuador: Public Health Ministry
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Mexico: Ministry of Health
Panama: Ministry of Health
Philippines: Bureau of Food and Drugs
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Venezuela: Ministry of Health and Social Development