Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00624065
First received: February 14, 2008
Last updated: February 7, 2013
Last verified: February 2013
Results First Received: June 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: carvedilol controlled release/lisinopril
Drug: lisinopril + 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lisinopril Lisinopril monotherapy (10, 20, or 40 mg once daily)
Carvedilol CR + Lisinopril Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)

Participant Flow:   Overall Study
    Lisinopril     Carvedilol CR + Lisinopril  
STARTED     216     216  
COMPLETED     197     192  
NOT COMPLETED     19     24  
Adverse Event                 5                 6  
Lost to Follow-up                 4                 1  
Consent withdrawn                 6                 5  
Lack of Efficacy                 0                 3  
Met protocol-defined stopping criteria                 4                 9  



  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
Lisinopril Lisinopril monotherapy (10, 20, or 40 mg once daily)
Carvedilol CR + Lisinopril Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
Total Total of all reporting groups

Baseline Measures
    Lisinopril     Carvedilol CR + Lisinopril     Total  
Number of Participants  
[units: participants]
  216     216     432  
Age  
[units: years]
Mean ± Standard Deviation
  54.0  ± 11.9     54.1  ± 9.8     54.1  ± 10.9  
Gender  
[units: participants]
     
Female     95     95     190  
Male     121     121     242  
Race/Ethnicity, Customized  
[units: Participants]
     
African American/African Heritage (AA/AH)     45     29     74  
American Indian or Alaska Native     1     2     3  
Japanese/East Asian/South East Asian Heritage     16     6     22  
Mixed Asian Heritage     1     0     1  
White     150     178     328  
AA/AH & American Indian or Alaska Native     2     0     2  
AA/AH & American Indian or Alaska Native & White     1     0     1  
AA/AH & White     0     1     1  
Baseline Blood Pressure  
[units: mm/Hg]
Mean ± Standard Deviation
     
Baseline Sitting Systolic Blood Pressure (SBP)     149.8  ± 10.25     148.8  ± 10.30     149.3  ± 10.27  
Baseline Sitting Diastolic Blood Pressure (DBP)     92.2  ± 8.12     92.2  ± 6.84     92.2  ± 7.50  



  Outcome Measures
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1.  Primary:   Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment   [ Time Frame: Week 6 ]

2.  Secondary:   Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6   [ Time Frame: Baseline and Week 6 ]


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00624065     History of Changes
Other Study ID Numbers: COR111096
Study First Received: February 14, 2008
Results First Received: June 11, 2009
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration