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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 used for?

SK&F-105517 is an investigational small molecule being developed for the treatment of hypertension, a condition of high blood pressure. It is currently in Phase 1 clinical development, meaning it is still being tested in early-stage trials to evaluate its safety and how it works in the body.

Who makes SK&F-105517?

SK&F-105517 is being developed by GSK plc, a global pharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting clinical research on this drug candidate for hypertension.

What phase is SK&F-105517 in?

SK&F-105517 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for hypertension.

What clinical trials is SK&F-105517 in?

SK&F-105517 has one completed clinical trial registered under NCT00537043, titled "A Study to Compare COREG CR to COREG CR Fixed-dose Combination in Patients With High Blood Pressure." This Phase 1 study enrolled 24 participants with hypertension in the United States.

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

SK&F-105517 is not the same as COREG CR. The clinical trial NCT00537043 compares COREG CR to a fixed-dose combination that includes COREG CR, and SK&F-105517 is the investigational drug being studied in this context. They are distinct entities.