To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01070043
First received: February 6, 2010
Last updated: September 13, 2011
Last verified: September 2011
Results First Received: September 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hypertension
High Blood Pressure
Interventions: Drug: Amlodipine 5mg/Valsartan 80 mg
Drug: Valsartan

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A 4 week run-in phase preceded the randomized, double-blind treatment phase of the study. During the run-in phase, participants took valsartan 80 mg daily before a meal. Sixty participants entered the run-in phase. Those participants who met the inclusion criteria entered the randomized, double-blind treatment phase.

Reporting Groups
  Description
Run-In Valsartan 80 mg During run-in period, oral valsartan 80 mg once daily for 4 weeks.
Amlodipine 5 mg/Valsartan 80 mg During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
Valsartan 160 mg In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.

Participant Flow for 2 periods

Period 1:   Run-In Phase
    Run-In Valsartan 80 mg     Amlodipine 5 mg/Valsartan 80 mg     Valsartan 160 mg  
STARTED     60     0 [1]   0 [2]
COMPLETED     42     0     0  
NOT COMPLETED     18     0     0  
Did not Meet Inclusion Criteria                 18                 0                 0  
[1] This combination therapy arm is used only for double-blind phase.
[2] This monotherapy (Valsartan 160 mg) treatment arm is used only for double-blind phase.

Period 2:   Double-Blind Treatment
    Run-In Valsartan 80 mg     Amlodipine 5 mg/Valsartan 80 mg     Valsartan 160 mg  
STARTED     0     21     21  
COMPLETED     0     21     19  
NOT COMPLETED     0     0     2  
Adverse Event                 0                 0                 2  



  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
Amlodipine 5mg/Valsartan 80 mg During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
Valsartan 160 mg In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Amlodipine 5mg/Valsartan 80 mg     Valsartan 160 mg     Total  
Number of Participants  
[units: participants]
  21     21     42  
Age [1]
[units: years]
Mean ± Standard Deviation
  59.50  ± 13.81     55.13  ± 11.81     57.31  ± 13.81  
Gender  
[units: participants]
     
Female     9     8     17  
Male     12     13     25  
[1] Baseline measurements were based on safety/intent-to-treat (ITT) population.



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement   [ Time Frame: Baseline and 8 weeks ]

2.  Primary:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement   [ Time Frame: Baseline and 8 weeks ]

3.  Secondary:   Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours   [ Time Frame: Baseline and 8 weeks ]

4.  Secondary:   Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase   [ Time Frame: Baseline and 8 weeks ]

5.  Secondary:   Number of Participants With Adverse Events During Double-blind Phase   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


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


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01070043     History of Changes
Other Study ID Numbers: CVAA489ATW01
Study First Received: February 6, 2010
Results First Received: September 13, 2011
Last Updated: September 13, 2011
Health Authority: Taiwan: Department of Health