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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_567 |
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This study will measure and compare changes in insulin production and sensitivity using the hyperglycemic clamp technique in obese patients with impaired glucose tolerance and hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide (HCTZ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I, Placebo-HCTZ | Experimental | Placebo in Period 1 followed by HCTZ in Period 2 |
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| Part I, HCTZ-Placebo | Experimental | HCTZ in Period 1, followed by placebo in Period 2 |
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| Part II, Placebo-ISMN | Experimental | Placebo in Period 1, followed by ISMN in Period 2 |
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| Part II, ISMN-Placebo | Experimental | ISMN in Period 1, followed by placebo in Period 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrochlorothiazide (HCTZ) | Drug | HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT) | Steady state was defined as 90-120 minutes post-dose. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. | 90 -120 minutes post-dose |
| Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG) | Steady state was defined as 90-120 minutes post-dose. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening. | 90 -120 minutes post-dose |
| Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT) | Steady state was defined as 90-120 minutes post-dose. NGT participants (FPG <100 mg/dL & 2 hour plasma glucose (PG) <140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG). IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. IFG was defined as FPG between 100 and 125 mg/dL at screening. | 90 -120 minutes post-dose |
| Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state | Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. | 90 -120 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT) | Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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Enrolled participants were place into two periods. 36 Part I participants received Hydrochlorothiazide (HCTZ) first, then placebo or placebo first, then HCTZ. A new group of 28 Part II participants received Isosorbide Mononitrate (ISMN) first, then placebo or placebo first, then ISMN.
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| ID | Title | Description |
|---|---|---|
| FG000 | HCTZ First, Then HCTZ Placebo | Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2 |
| FG001 | HCTZ Placebo First, Then HCTZ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part I |
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| Comparator: Placebo to HCTZ | Drug | Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period |
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| Isosorbide mononitrate (ISMN) | Drug | ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period |
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| Comparator: Placebo to ISMN | Drug | Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period |
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| 90 -120 minutes post-dose |
| Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG) | Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening. | 90 -120 minutes post-dose |
| Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT) | Steady state was defined as 90-120 minutes post-dose. The ratio was the measure of the quantity of glucose disposed per unit of plasma insulin concentration (PIC). Approximate PIC was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals, time = 90, 100, 110, and 120 minutes. NGT participants (FPG <100 mg/dL & 2 hour PG <140 mg/dL during a 75g OGTT at screening) were neither IGT nor IFG at screening. IGT - defined as a 2 hour PG >= 140 and <= 199 mg/dL during a 75g OGTT at screening. IFG - defined as FPG between 100 and 125 mg/dL at screening. | 90 -120 minutes post-dose |
Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
| FG002 | ISMN First, Then ISMN Placebo | Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2 |
| FG003 | ISMN Placebo First, Then ISMN | Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2 |
| COMPLETED |
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| NOT COMPLETED |
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| Part II |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Part I Participants | Part I Overall: Hydrochlorothiazide (HCTZ) in Period 1 followed by Placebo in Period 2 or Placebo in Period 1, followed by HCTZ in Period 2 |
| BG001 | All Part II Participants | Part II Overall: Isosorbide mononitrate (ISMN)in Period 1, followed by placebo in Period 2 or placebo in Period 1, followed by ISMN in Period 2 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT) | Steady state was defined as 90-120 minutes post-dose. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. | Number of participants with IGT. | Posted | Least Squares Mean | Standard Deviation | ng/minute | 90 -120 minutes post-dose |
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| Primary | Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG) | Steady state was defined as 90-120 minutes post-dose. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening. | Number of participants with IFG. | Posted | Least Squares Mean | Standard Deviation | ng/minute | 90 -120 minutes post-dose |
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| Secondary | Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT) | Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. | Number of participants with IGT. | Posted | Least Squares Mean | Standard Deviation | (mg/kg/minute)/(µIU/mL) | 90 -120 minutes post-dose |
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| Primary | Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT) | Steady state was defined as 90-120 minutes post-dose. NGT participants (FPG <100 mg/dL & 2 hour plasma glucose (PG) <140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG). IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. IFG was defined as FPG between 100 and 125 mg/dL at screening. | Number of participants with NGT. | Posted | Least Squares Mean | Standard Deviation | ng/minute | 90 -120 minutes post-dose |
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| Primary | Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state | Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. | Number of participants who took ISMN/placebo. | Posted | Least Squares Mean | Standard Deviation | (mg/kg/minute)/(µIU/mL) | 90 -120 minutes post-dose |
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| Secondary | Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG) | Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening. | Number of participants with IFG. | Posted | Least Squares Mean | Standard Deviation | (mg/kg/minute)/(µIU/mL) | 90 -120 minutes post-dose |
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| Secondary | Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT) | Steady state was defined as 90-120 minutes post-dose. The ratio was the measure of the quantity of glucose disposed per unit of plasma insulin concentration (PIC). Approximate PIC was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals, time = 90, 100, 110, and 120 minutes. NGT participants (FPG <100 mg/dL & 2 hour PG <140 mg/dL during a 75g OGTT at screening) were neither IGT nor IFG at screening. IGT - defined as a 2 hour PG >= 140 and <= 199 mg/dL during a 75g OGTT at screening. IFG - defined as FPG between 100 and 125 mg/dL at screening. | Number of participants with NGT. | Posted | Least Squares Mean | Standard Deviation | (mg/kg/minute)/(µIU/mL) | 90 -120 minutes post-dose |
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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 | HCTZ | Part I: Participants on HCTZ in either Period 1 or Period 2 | 0 | 36 | 29 | 36 | ||
| EG001 | HCTZ Placebo | Part I: Participants on HCTZ Placebo in either Period 1 or Period 2 | 0 | 36 | 25 | 36 | ||
| EG002 | ISMN | Part II: Participants on ISMN in either Period 1 or Period 2 | 0 | 28 | 26 | 28 | ||
| EG003 | ISMN Placebo | Part II: Participants on ISMN Placebo in either Period 1 or Period 2 | 0 | 28 | 17 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Back injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Blood pressure inadequately controlled | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Ear discomfort | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Oliguria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Protein urine present | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| C030397 | isosorbide-5-mononitrate |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Withdrawal by Subject |
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| Adverse Event |
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| Protocol Violation |
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| Male |
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