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SK&F-105517

Phase 1

Hypertension | Small molecule | Cardiovascular |GSK plc|Last Updated: Oct 19, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

SK&F-105517 · 1 trial · 1 indication

Phase 1 1
NCT00537043A Study to Compare COREG CR to COREG CR Fixed-dose Combination in Patients With High Blood PressureHypertension
COMPLETED24 Analytics
PHASE1COMPLETED
A Study to Compare COREG CR to COREG CR Fixed-dose Combination in Patients With High Blood Pressure
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Comparison of the amount of SB-568859 found in the blood after a 7 days of dosing with carvedilol controlled release and carvedilol controlled release plus lisinopril
7 days

Secondary Endpoints

Assessment of the safety and tolerability of carvedilol controlled release and the fixed dose combination based on blood and urine tests, vital signs, and reporting of side effects.
7 days
The pharmacokinetic parameters to be evaluated are the Tmax, Ct, and t1/2 of carvedilol [R(+)- and S(-)-enantiomers] when administered as the FDC formulation compared to COREG CR alone.
Safety and tolerability as assessed by clinical data from AE reporting, nurse/physician observations, vital signs, ECGs and safety laboratory tests.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
SK&F-105517 (COREG CR FDC)DRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Adult males or females of non-child bearing potential who are between 18 and 60 years old. * Have a history of mild to moderate essential hypertension or present with mild to moderate essential hypertension defined by Diastolic Blood Pressure \>/90 and \</109 mmHg, and/or Syst...

Countries:United States
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Frequently asked questions about SK&F-105517

What is SK&F-105517?

SK&F-105517 is an investigational small molecule developed by GSK plc for hypertension. It is also referred to as SK&F-105517 (COREG CR FDC), indicating it was studied as a fixed-dose combination with COREG CR. It is in Phase 1 clinical development.

What is SK&F-105517 used for?

SK&F-105517 is being studied for the treatment of hypertension, also known as high blood pressure. The only clinical trial of this agent enrolled patients with high blood pressure. It has not been approved for any indication.

Who is developing SK&F-105517?

SK&F-105517 is being developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 trial of the fixed-dose combination with COREG CR in patients with hypertension.

What phase is SK&F-105517 in?

SK&F-105517 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug remains investigational and has not been approved by the FDA or any regulatory agency.

What clinical trials is SK&F-105517 in?

SK&F-105517 has been evaluated in one completed Phase 1 trial, NCT00537043, titled "A Study to Compare COREG CR to COREG CR Fixed-dose Combination in Patients With High Blood Pressure." The trial enrolled 24 patients with hypertension in the United States and was randomized but uncontrolled.

Is SK&F-105517 the same as COREG CR FDC?

SK&F-105517 is also known as SK&F-105517 (COREG CR FDC). The parenthetical name reflects its study as a fixed-dose combination with COREG CR. COREG CR alone is a separate approved product, and SK&F-105517 refers specifically to the combination agent.