Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00437645
First received: February 16, 2007
Last updated: March 31, 2011
Last verified: March 2011
Results First Received: August 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Essential Hypertension
Interventions: Drug: Valsartan 160 mg capsules
Drug: Amlodipine 5 mg capsules
Drug: placebo

  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
No text entered.

Reporting Groups
  Description
Valsartan/Amlodipine 160/5 mg Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
Amlodipine 10 mg Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.

Participant Flow:   Overall Study
    Valsartan/Amlodipine 160/5 mg     Amlodipine 10 mg  
STARTED     592     591  
COMPLETED     557     476  
NOT COMPLETED     35     115  
Adverse Event                 15                 84  
Withdrawal by Subject                 10                 22  
Protocol Violation                 3                 3  
Lost to Follow-up                 2                 3  
Administrative problems                 2                 1  
Lack of Efficacy                 2                 1  
Condition no longer requires study drug                 1                 1  



  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.
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Reporting Groups
  Description
Valsartan/Amlodipine 160/5 mg Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
Amlodipine 10 mg Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
Total Total of all reporting groups

Baseline Measures
    Valsartan/Amlodipine 160/5 mg     Amlodipine 10 mg     Total  
Number of Participants  
[units: participants]
  592     591     1183  
Age  
[units: AgeĀ (years)]
Mean ± Standard Deviation
     
Overall study     65.6  ± 7.56     65.4  ± 7.16     65.5  ± 7.36  
Gender  
[units: participants]
     
Female     285     284     569  
Male     307     307     614  



  Outcome Measures
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1.  Primary:   Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8   [ Time Frame: Baseline to Week 8 ]

2.  Primary:   Percentage of Patients With Peripheral Edema From Baseline to Week 8   [ Time Frame: Baseline to Week 8 ]

3.  Secondary:   Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8   [ Time Frame: Baseline to Week 8 ]

4.  Secondary:   Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12   [ Time Frame: Baseline to Weeks 4, 8, and 12 ]

5.  Secondary:   Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12   [ Time Frame: Baseline to Weeks 4, 8, and 12 ]


  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: Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00437645     History of Changes
Other Study ID Numbers: CVAA489A2404
Study First Received: February 16, 2007
Results First Received: August 17, 2009
Last Updated: March 31, 2011
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Argentina: Ministry of Health
Chile: Instituto de Salud Publica de Chile
Ecuador: Public Health Ministry
Germany: BfArM
Norway: Norwegian Medicines Agency
Spain: Spanish Agency of Medicines
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health