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Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01918332
First received: August 5, 2013
Last updated: December 8, 2014
Last verified: December 2014
Results First Received: April 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Hypertension,
Hyperlipidemia
Interventions: Drug: Valsartan 160mg
Drug: Rosuvastatin 20mg
Drug: Valsartan 160mg placebo
Drug: Rosuvastatin 20mg 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 160mg, Rosuvastatin 20mg

Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.

Valsartan 160mg

Rosuvastatin 20mg

Valsartan 160mg, Rosuvastatin 20mg Placebo

Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.

Valsartan 160mg

Rosuvastatin 20mg placebo

Valsartan 160mg Placebo, Rosuvastatin 20mg

Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.

Rosuvastatin 20mg

Valsartan 160mg placebo

Placebo

Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.

Valsartan 160mg placebo

Rosuvastatin 20mg placebo


Participant Flow:   Overall Study
    Valsartan 160mg, Rosuvastatin 20mg     Valsartan 160mg, Rosuvastatin 20mg Placebo     Valsartan 160mg Placebo, Rosuvastatin 20mg     Placebo  
STARTED     43     41     39     45  
COMPLETED     35     36     30     38  
NOT COMPLETED     8     5     9     7  
Adverse Event                 0                 0                 0                 1  
Withdrawal by Subject                 2                 3                 2                 3  
Protocol Violation                 6                 2                 6                 3  
lipid result by central lab did not meet                 0                 0                 1                 0  



  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.
Full Analysis Set

Reporting Groups
  Description
Valsartan 160mg, Rosuvastatin 20mg

Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.

Valsartan 160mg

Rosuvastatin 20mg

Valsartan 160mg, Rosuvastatin 20mg Placebo

Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.

Valsartan 160mg

Rosuvastatin 20mg placebo

Valsartan 160mg Placebo, Rosuvastatin 20mg

Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.

Rosuvastatin 20mg

Valsartan 160mg placebo

Placebo

Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.

Valsartan 160mg placebo

Rosuvastatin 20mg placebo

Total Total of all reporting groups

Baseline Measures
    Valsartan 160mg, Rosuvastatin 20mg     Valsartan 160mg, Rosuvastatin 20mg Placebo     Valsartan 160mg Placebo, Rosuvastatin 20mg     Placebo     Total  
Number of Participants  
[units: participants]
  41     40     35     44     160  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     26     24     21     29     100  
>=65 years     15     16     14     15     60  
Gender  
[units: participants]
         
Female     16     14     7     10     47  
Male     25     26     28     34     113  



  Outcome Measures
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1.  Primary:   sitDBP Changes at Week 8 From Baseline   [ Time Frame: 8 weeks ]

2.  Primary:   LDL-C Percentage Changes at Week 8 From Baseline   [ 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
Withdrawal(discontinuation) leading to smaller number of per-protocol set than full analysis set. The violation of protocol was the criterion of subjects' withdrawal.


  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: Prof. YangSoo Jang
Organization: Yonsei University Healthcare System Severance Hospital
phone: 82-2-6924-3109
e-mail: yejung@lgls.com


No publications provided


Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01918332     History of Changes
Other Study ID Numbers: LG-VRCL002
Study First Received: August 5, 2013
Results First Received: April 24, 2014
Last Updated: December 8, 2014
Health Authority: Korea: Ministry of Food and Drug Safety