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| Name | Class |
|---|---|
| Merck Ltd. | INDUSTRY |
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At present, there is some clinical data for different functional response to beta-blockers associated with beta-adrenergic receptor polymorphisms. But there has been no data reported, about the incidence of beta-adrenergic receptor polymorphism and association with beta-adrenergic receptor polymorphism and response to beta-blocker therapy in Korean heart failure (HF) subjects. This single-arm, open-label, multicentric study is designed with the purpose of analyzing the association between genetic polymorphism of beta-adrenergic receptor and the effects of beta-blocker (bisoprolol) in Korean HF subjects.
Heart failure impairs the quality of life of an individual and is considered to be the main cause of morbidity and mortality. Prognosis of HF subjects depends on severity, age and sex. Subjects with HF require lifelong treatment. Pharmacological treatment aims to improve both the quality of life and survival of HF subjects.
OBJECTIVES:
Primary objective:
Secondary objective:
The method involved in this study will be as follows:
Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisoprolol | Drug | Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or End of Treatment (EOT) | Baseline and Week 26 (or EOT) | |
| Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline and Week 26 (or EOT) | |
| Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline and Week 26 (or EOT) | |
| Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of G Protein-coupled Receptor Kinase 5 (GRK5)-AG at Week 26 or EOT | Baseline and Week 26 (or EOT) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hospitalization Due to Heart Failure | Baseline to Week 26 (or EOT) | |
| Duration of Hospitalization Due to Heart Failure | Baseline to Week 26 (or EOT) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea Seoul St. Mary's Hospital, 505, Banpodong, SeoChoGu | Seoul | South Korea |
A total of 117 participants were screened for the study, out of which 17 were screen failures and 100 participants received the study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bisoprolol | Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bisoprolol | Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or End of Treatment (EOT) | Efficacy intention to treat (ITT) population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | Percent LVEF | Baseline and Week 26 (or EOT) |
|
Up to Week 26 (or EOT)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bisoprolol | Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death sudden | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT |
6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. |
| Baseline and Week 26 (or EOT) |
| Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | 6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline and Week 26 (or EOT) |
| Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | 6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline and Week 26 (or EOT) |
| Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | 6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Systolic Blood Pressure (SBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Diastolic Blood Pressure (DBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Pro-B-type Natriuretic Peptide (BNP) Levels According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. | Baseline and Week 26 (or EOT) |
| Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. | Baseline and Week 26 (or EOT) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Number of Participants With Hospitalization Due to Heart Failure | Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. | Posted | Number | Participants | Baseline to Week 26 (or EOT) |
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| Secondary | Duration of Hospitalization Due to Heart Failure | Participant analyzed included 1 participant from the efficacy ITT population who was hospitalized once due to heart failure. | Posted | Number | Days | Baseline to Week 26 (or EOT) |
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| Secondary | Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | 6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | Meter | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | 6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | Meter | Baseline and Week 26 (or EOT) |
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| Primary | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | Percent LVEF | Baseline and Week 26 (or EOT) |
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| Primary | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | Percent LVEF | Baseline and Week 26 (or EOT) |
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| Primary | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of G Protein-coupled Receptor Kinase 5 (GRK5)-AG at Week 26 or EOT | Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | Percent LVEF | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | 6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | Meter | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | 6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | Meter | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | Beats per minute (bpm) | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | bpm | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | bpm | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | bpm | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | bpm | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | bpm | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | bpm | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | bpm | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
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| Secondary | Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
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|
| Secondary | Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline. | Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in Pro-B-type Natriuretic Peptide (BNP) Levels According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT | BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. | Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | picograms (pg)/ milliliter (mL) | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. | Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. | Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Week 26 (or EOT) |
|
|
|
| Secondary | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. | Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. "n" signifies number of participants with particular genotype and were evaluated for this outcome at particular time point. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Week 26 (or EOT) |
|
|
|
| 7 |
| 100 |
| 93 |
| 100 |
| Edema limbs | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| INR increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment |
|
| Chest discomfort | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| General body pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pitting edema | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Weakness generalized | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Back discomfort | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Near syncope | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Orthostatic dizziness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Sleepiness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Slurred speech | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tingling feet/hands | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Voiding difficulty | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nipple pain | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Common cold | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dry cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Sputum | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
Not provided
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg389Arg (n= 53) |
|
| Change at Week 26 or EOT: Arg389Gly (n= 24) |
|
| Change at Week 26 or EOT: Gly389Gly (n= 5) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg16Arg (n= 14) |
|
| Change at Week 26 or EOT: Arg16Gly (n= 41) |
|
| Change at Week 26 or EOT: Gly16Gly (n= 27) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg16Arg (n= 14) |
|
| Change at Week 26 or EOT: Arg16Gly (n= 41) |
|
| Change at Week 26 or EOT: Gly16Gly (n= 28) |
|
|
| Change at Week 26 or EOT: Glu27Glu (n= 1) |
|
| Change at Week 26 or EOT: Glu27Gln (n= 15) |
|
| Change at Week 26 or EOT: Gln27Gln (n= 67) |
|
|
| Change at Week 26 or EOT: GRK5-Arg304 (n= 50) |
|
| Change at Week 26 or EOT: GRK5-Arg304His (n= 30) |
|
| Change at Week 26 or EOT: GRK5-His304 (n= 3) |
|
|
| Change at Week 26 or EOT: Glu27Glu (n= 1) |
|
| Change at Week 26 or EOT: Glu27Gln (n= 15) |
|
| Change at Week 26 or EOT: Gln27Gln (n= 66) |
|
|
| Change at Week 26 or EOT: GRK5-Arg304 (n= 49) |
|
| Change at Week 26 or EOT: GRK5-Arg304His (n= 30) |
|
| Change at Week 26 or EOT: GRK5-His304 (n= 3) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg389Arg (n= 53) |
|
| Change at Week 26 or EOT: Arg389Gly (n= 24) |
|
| Change at Week 26 or EOT: Gly389Gly (n= 5) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg16Arg (n= 14) |
|
| Change at Week 26 or EOT: Arg16Gly (n= 41) |
|
| Change at Week 26 or EOT: Gly16Gly (n= 27) |
|
|
| Change at Week 26 or EOT: Glu27Glu (n= 1) |
|
| Change at Week 26 or EOT: Glu27Gln (n= 15) |
|
| Change at Week 26 or EOT: Gln27Gln (n= 66) |
|
|
| Change at Week 26 or EOT: GRK5-Arg304 (n= 49) |
|
| Change at Week 26 or EOT: GRK5-Arg304His (n= 30) |
|
| Change at Week 26 or EOT: GRK5-His304 (n= 3) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg389Arg (n= 53) |
|
| Change at Week 26 or EOT: Arg389Gly (n= 24) |
|
| Change at Week 26 or EOT: Gly389Gly (n= 5) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg16Arg (n= 14) |
|
| Change at Week 26 or EOT: Arg16Gly (n= 41) |
|
| Change at Week 26 or EOT: Gly16Gly (n= 27) |
|
|
| Change at Week 26 or EOT: Glu27Glu (n= 1) |
|
| Change at Week 26 or EOT: Glu27Gln (n= 15) |
|
| Change at Week 26 or EOT: Gln27Gln (n= 66) |
|
|
| Change at Week 26 or EOT: GRK5-Arg304 (n= 49) |
|
| Change at Week 26 or EOT: GRK5-Arg304His (n= 30) |
|
| Change at Week 26 or EOT: GRK5-His304 (n= 3) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg389Arg (n= 52) |
|
| Change at Week 26 or EOT: Arg389Gly (n= 24) |
|
| Change at Week 26 or EOT: Gly389Gly (n= 5) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg16Arg (n= 14) |
|
| Change at Week 26 or EOT: Arg16Gly (n= 41) |
|
| Change at Week 26 or EOT: Gly16Gly (n= 26) |
|
|
| Change at Week 26 or EOT: Glu27Glu (n= 1) |
|
| Change at Week 26 or EOT: Glu27Gln (n= 15) |
|
| Change at Week 26 or EOT: Gln27Gln (n= 65) |
|
|
| Change at Week 26 or EOT: GRK5-Arg304 (n= 48) |
|
| Change at Week 26 or EOT: GRK5-Arg304His (n= 30) |
|
| Change at Week 26 or EOT: GRK5-His304 (n= 3) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg389Arg (n= 52) |
|
| Change at Week 26 or EOT: Arg389Gly (n= 24) |
|
| Change at Week 26 or EOT: Gly389Gly (n= 5) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg16Arg (n= 14) |
|
| Change at Week 26 or EOT: Arg16Gly (n= 41) |
|
| Change at Week 26 or EOT: Gly16Gly (n= 26) |
|
|
| Change at Week 26 or EOT: Glu27Glu (n= 1) |
|
| Change at Week 26 or EOT: Glu27Gln (n= 15) |
|
| Change at Week 26 or EOT: Gln27Gln (n= 65) |
|
|
| Change at Week 26 or EOT: GRK5-Arg304 (n= 48) |
|
| Change at Week 26 or EOT: GRK5-Arg304His (n= 30) |
|
| Change at Week 26 or EOT: GRK5-His304 (n= 3) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg389Arg (n= 52) |
|
| Change at Week 26 or EOT: Arg389Gly (n= 24) |
|
| Change at Week 26 or EOT: Gly389Gly (n= 5) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg16Arg (n= 14) |
|
| Change at Week 26 or EOT: Arg16Gly (n= 41) |
|
| Change at Week 26 or EOT: Gly16Gly (n= 26) |
|
|
| Change at Week 26 or EOT: Glu27Glu (n= 1) |
|
| Change at Week 26 or EOT: Glu27Gln (n= 15) |
|
| Change at Week 26 or EOT: Gln27Gln (n= 65) |
|
|
| Change at Week 26 or EOT: GRK5-Arg304 (n= 48) |
|
| Change at Week 26 or EOT: GRK5-Arg304His (n= 30) |
|
| Change at Week 26 or EOT: GRK5-His304 (n= 3) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg389Arg (n= 52) |
|
| Change at Week 26 or EOT: Arg389Gly (n= 24) |
|
| Change at Week 26 or EOT: Gly389Gly (n= 5) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg16Arg (n= 14) |
|
| Change at Week 26 or EOT: Arg16Gly (n= 41) |
|
| Change at Week 26 or EOT: Gly16Gly (n= 26) |
|
|
| Change at Week 26 or EOT: Glu27Glu (n= 1) |
|
| Change at Week 26 or EOT: Glu27Gln (n= 15) |
|
| Change at Week 26 or EOT: Gln27Gln (n= 65) |
|
|
| Change at Week 26 or EOT: GRK5-Arg304 (n= 48) |
|
| Change at Week 26 or EOT: GRK5-Arg304His (n= 30) |
|
| Change at Week 26 or EOT: GRK5-His304 (n= 3) |
|
|
| Change at Week 26 or EOT: Arg389Arg (n= 53) |
|
| Change at Week 26 or EOT: Arg389Gly (n= 24) |
|
| Change at Week 26 or EOT: Gly389Gly (n= 5) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 26 or EOT: Arg16Arg (n= 14) |
|
| Change at Week 26 or EOT: Arg16Gly (n= 40) |
|
| Change at Week 26 or EOT: Gly16Gly (n= 28) |
|
|
| Change at Week 26 or EOT: Glu27Glu (n= 1) |
|
| Change at Week 26 or EOT: Glu27Gln (n= 15) |
|
| Change at Week 26 or EOT: Gln27Gln (n= 66) |
|
|
| Change at Week 26 or EOT: GRK5-Arg304 (n= 49) |
|
| Change at Week 26 or EOT: GRK5-Arg304His (n= 30) |
|
| Change at Week 26 or EOT: GRK5-His304 (n= 3) |
|