September 27, 2007 |
October 15, 2008 |
October 2007 |
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 [ Time Frame: 7 days ] |
Same as current |
Complete list of historical versions of study NCT00537043 on ClinicalTrials.gov Archive Site |
- 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. [ Time Frame: 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.
|
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. [ Time Frame: 7 days ] |
|
A Study to Compare COREG CR to COREG CR Fixed-Dose Combination in Patients With High Blood Pressure |
An Open-Label, Randomized, Crossover, Repeat-Dose Study to Evaluate the Steady-State Pharmacokinetic Profile of the Final Fixed Dose Combination (FDC) Formulation of COREG CR and Lisinopril as Compared to COREG CR in Subjects With Essential Hypertension |
Carvedilol controlled release is a marketed drug to treat high blood pressure. This study is to compare carvedilol controlled release to carvedilol controlled release plus lisinopril (fixed-dose combination) after repeat dosing in patients with high blood pressure. This is to make sure that when carvedilol controlled release is given with lisinopril it acts the same in the body as when given alone. The study will also assess the safety and tolerability of the fixed-dose combination. |
|
Phase I |
Interventional |
Treatment, Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Hypertension |
Drug: SK&F-105517 (COREG CR FDC) |
|
|
|
Completed |
24 |
January 2008 |
January 2008 (final data collection date for primary outcome measure) |
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 Systolic Blood Pressure >/140 and </179 mmHg
- Body weight > 60 kg (132 pounds) and body mass index (BMI) between 19 and 35
Exclusion criteria:
|
Both |
18 Years to 60 Years |
No |
|
United States |
|
|
NCT00537043 |
Study Director, GSK |
|
GlaxoSmithKline |
|
Study Director: |
GSK Clinical Trials, MD |
GlaxoSmithKline |
|
|
GlaxoSmithKline |
October 2008 |