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

This study has been completed.

Study NCT00624065 Information provided by GlaxoSmithKline

First Received: February 14, 2008 Last Updated: September 11, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Condition:	Stage 1 or 2 Essential Hypertension
Interventions:	Drug: lisinopril + placebo Drug: carvedilol controlled release/lisinopril

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Consent withdrawn	6	5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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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)

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 [ Week 6 ]

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2. Secondary:

Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6 [ Baseline and Week 6 ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	The frequency threshold for reporting Other Adverse Events is 1% in either treatment group.

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)

Serious Adverse Events

	Lisinopril	Carvedilol CR + Lisinopril
Total, serious adverse events
# participants affected	2	3
Cardiac disorders
Cardiac failure ^†^A # participants affected / at risk	1/216 (0.46%)	0/216 (0.00%)
Gastrointestinal disorders
Gastroesophageal reflux disease ^†^A # participants affected / at risk	0/216 (0.00%)	1/216 (0.46%)
General disorders
Non-cardiac chest pain ^†^A # participants affected / at risk	0/216 (0.00%)	1/216 (0.46%)
Infections and infestations
Meningitis viral ^†^A # participants affected / at risk	0/216 (0.00%)	1/216 (0.46%)
Injury, poisoning and procedural complications
Overdose ^†^A # participants affected / at risk	1/216 (0.46%)	0/216 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer ^†^A # participants affected / at risk	0/216 (0.00%)	1/216 (0.46%)
Nervous system disorders
Headache ^†^A # participants affected / at risk	0/216 (0.00%)	1/216 (0.46%)
Psychiatric disorders
Suicide attempt ^†^A # participants affected / at risk	1/216 (0.46%)	0/216 (0.00%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA

Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	COR111096
Study First Received:	February 14, 2008
Results First Received:	June 11, 2009
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00624065 History of Changes
Health Authority:	United States: Food and Drug Administration