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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_004 |
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The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure).
This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High BMI:MK-0736 2mg→Placebo | Experimental | Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) |
|
| High BMI:MK-0736 7mg→Placebo | Experimental | Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) |
|
| High BMI:MK-0916 6mg→MK-0916 6mg | Experimental | Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
|
| High BMI:Placebo→Placebo | Placebo Comparator | Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
|
| Low BMI:MK-0916 6mg→MK-0916 6mg | Experimental | Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0736 | Drug |
| ||
| MK0916 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded. | Baseline and Week 12 (end of Phase A) |
| Number of Participants Who Reported a Clinical Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. | 24 weeks |
| Number of Participants Who Reported a Laboratory Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. | 24 weeks |
| Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded. | Baseline and Week 12 (end of Phase A) |
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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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21419745 | Derived | Shah S, Hermanowski-Vosatka A, Gibson K, Ruck RA, Jia G, Zhang J, Hwang PM, Ryan NW, Langdon RB, Feig PU. Efficacy and safety of the selective 11beta-HSD-1 inhibitors MK-0736 and MK-0916 in overweight and obese patients with hypertension. J Am Soc Hypertens. 2011 May-Jun;5(3):166-76. doi: 10.1016/j.jash.2011.01.009. Epub 2011 Mar 21. |
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Enrolled participants were divided into 2 strata: higher body mass index (BMI) (27 kg/m^2≤BMI<41 kg/m^2) and lower BMI (20 kg/m^2≤BMI<27 kg/m^2) prior to being randomly assigned study treatment. Data from High BMI groups were to be utilized in the primary and secondary analyses; data from low BMI groups were to be utilized in exploratory analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | High BMI:MK-0736 2mg→Placebo | Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) |
| FG001 | High BMI:MK-0736 7mg→Placebo | Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) |
| FG002 | High BMI:MK-0916 6mg→MK-0916 6mg | Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| FG003 | High BMI:Placebo→Placebo | Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| FG004 | Low BMI:MK-0916 6mg→MK-0916 6mg | Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| FG005 | Low BMI:Placebo→Placebo | Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase A |
|
| ||||||||||||||||||
| Phase B |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High BMI:MK-0736 2mg→Placebo | Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) |
| BG001 | High BMI:MK-0736 7mg→Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded. | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | Posted | Mean | Standard Deviation | mm Hg | Baseline and Week 12 (end of Phase A) |
|
24 weeks
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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 | High BMI:MK-0736 2mg→Placebo | Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C585925 | MK-0916 |
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| Low BMI:Placebo→Placebo | Placebo Comparator | Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
|
| Drug |
|
| Placebo | Drug |
|
| 24 weeks |
| Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. | 24 weeks |
| Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis. | Baseline and Week 12 (end of Phase A) |
| Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI | Waist circumference measured in cm at baseline and after 12 weeks of study drug administration | Baseline and Week 12 (end of Phase A) |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) | LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 (end of Phase A) |
| Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI | HDL-C measured at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 (end of Phase A) |
| Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI) | TG measured at baseline and after 12 weeks of study drug administration | Baseline and Week 12 (end of Phase A) |
| Participant moved |
|
| Site Terminated |
|
| Protocol Violation |
|
| Met criteria for discontinuation |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| Completed but did not enter Phase B |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
| BG002 | High BMI:MK-0916 6mg→MK-0916 6mg | Participants who received MK-0916 6 mg in Phase A and continued on MK-0916 6 mg for 12 weeks in Phase B |
| BG003 | High BMI:Placebo→Placebo | Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| BG004 | Low BMI:MK-0916 6mg→MK-0916 6mg | Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| BG005 | Low BMI:Placebo→Placebo | Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | MK-0736 7.0 mg High BMI | Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks |
| OG002 | MK-0916 6.0 mg High BMI | Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks |
| OG003 | Placebo High BMI | Participants administered placebo tablet once daily for 12 weeks |
|
|
|
| Secondary | Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded. | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | Posted | Mean | Standard Deviation | mm Hg | Baseline and Week 12 (end of Phase A) |
|
|
|
|
| Secondary | Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis. | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | Posted | Mean | Standard Deviation | kg | Baseline and Week 12 (end of Phase A) |
|
|
|
|
| Secondary | Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI | Waist circumference measured in cm at baseline and after 12 weeks of study drug administration | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | Posted | Mean | Standard Deviation | cm | Baseline and Week 12 (end of Phase A) |
|
|
|
|
| Secondary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) | LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration. | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | Posted | Mean | Standard Deviation | percentage change | Baseline and Week 12 (end of Phase A) |
|
|
|
|
| Secondary | Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI | HDL-C measured at baseline and after 12 weeks of study drug administration. | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 12 (end of Phase A) |
|
|
|
|
| Secondary | Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI) | TG measured at baseline and after 12 weeks of study drug administration | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 12 (end of Phase A) |
|
|
|
|
| Primary | Number of Participants Who Reported a Clinical Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. | All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy. | Posted | Number | Participants | 24 weeks |
|
|
|
| Primary | Number of Participants Who Reported a Laboratory Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. | All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy. | Posted | Number | Participants | 24 weeks |
|
|
|
| Primary | Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. | All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy. | Posted | Number | Participants | 24 weeks |
|
|
|
| Primary | Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. | All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy. | Posted | Number | Participants | 24 weeks |
|
|
|
| 2 |
| 54 |
| 40 |
| 54 |
| EG001 | High BMI:MK-0736 7mg→Placebo | Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) | 1 | 54 | 39 | 54 |
| EG002 | High BMI:MK-0916 6mg→MK-0916 6mg | Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | 2 | 52 | 37 | 52 |
| EG003 | High BMI:Placebo→Placebo | Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | 1 | 51 | 37 | 51 |
| EG004 | Low BMI:MK-0916 6mg→MK-0916 6mg | Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | 2 | 19 | 16 | 19 |
| EG005 | Low BMI:Placebo→Placebo | Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | 1 | 19 | 11 | 19 |
| Ileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anaphylactic Reaction | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Meningitis Bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lichen Sclerosus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Change Of Bowel Habit | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lip Swelling | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fluid Retention | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Postmenopausal Haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
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.
| ANCOVA |
Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable |
| 0.108 |
| Mean Difference (Final Values) |
| -3.9 |
| Standard Error of the Mean |
| 2.4 |
| 2-Sided |
| 95 |
| -8.7 |
| 0.9 |
| No |
| Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable | 0.099 | Mean Difference (Final Values) | -4.1 | Standard Error of the Mean | 2.5 | 2-Sided | 95 | -9.0 | 0.8 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable | 0.752 | Mean Difference (Final Values) | -0.8 | Standard Error of the Mean | 2.5 | 2-Sided | 95 | -5.7 | 4.1 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable | 0.941 | Mean Difference (Final Values) | 0.2 | Standard Error of the Mean | 2.5 | 2-Sided | 95 | -4.7 | 5.0 | No | Superiority or Other |
| ANCOVA |
Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable |
| 0.003 |
| Mean Difference (Final Values) |
| -1.1 |
| Standard Error of the Mean |
| 0.4 |
| 2-Sided |
| 95 |
| -1.9 |
| -0.4 |
| No |
| Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable | <0.001 | Mean Difference (Final Values) | -1.7 | Standard Error of the Mean | 0.4 | 2-Sided | 95 | -2.4 | -1.0 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable | 0.462 | Mean Difference (Final Values) | 0.3 | Standard Error of the Mean | 0.4 | 2-Sided | 95 | -0.5 | 1.0 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable | 0.118 | Mean Difference (Final Values) | 0.6 | Standard Error of the Mean | 0.4 | 2-Sided | 95 | -0.2 | 1.3 | No | Superiority or Other |
| ANCOVA |
Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable |
| <0.001 |
| Mean Difference (Final Values) |
| -3.6 |
| Standard Error of the Mean |
| 1.0 |
| 2-Sided |
| 95 |
| -5.5 |
| -1.7 |
| No |
| Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable | 0.136 | Mean Difference (Final Values) | -1.4 | Standard Error of the Mean | 0.9 | 2-Sided | 95 | -3.3 | 0.5 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable | 0.686 | Mean Difference (Final Values) | -0.4 | Standard Error of the Mean | 0.9 | 2-Sided | 95 | -2.2 | 1.4 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable | 0.022 | Mean Difference (Final Values) | -2.2 | Standard Error of the Mean | 0.9 | 2-Sided | 95 | -4.0 | -0.3 | No | Superiority or Other |
| ANCOVA |
Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable |
| 0.066 |
| Mean Difference (Final Values) |
| -8.1 |
| Standard Error of the Mean |
| 4.4 |
| 2-Sided |
| 95 |
| -16.7 |
| 0.5 |
| No |
| Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable | 0.319 | Mean Difference (Final Values) | -4.5 | Standard Error of the Mean | 4.5 | 2-Sided | 95 | -13.4 | 4.4 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable | 0.077 | Mean Difference (Final Values) | -7.8 | Standard Error of the Mean | 4.4 | 2-Sided | 95 | -16.4 | 0.8 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable | 0.418 | Mean Difference (Final Values) | -3.6 | Standard Error of the Mean | 4.4 | 2-Sided | 95 | -12.2 | 5.1 | No | Superiority or Other |
| ANCOVA |
Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable |
| 0.124 |
| Mean Difference (Final Values) |
| -4.0 |
| Standard Error of the Mean |
| 2.6 |
| 2-Sided |
| 95 |
| -9.2 |
| 1.1 |
| No |
| Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable | 0.429 | Mean Difference (Final Values) | 2.1 | Standard Error of the Mean | 2.6 | 2-Sided | 95 | -3.1 | 7.2 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable | 0.001 | Mean Difference (Final Values) | -8.3 | Standard Error of the Mean | 2.5 | 2-Sided | 95 | -13.3 | -3.4 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable | 0.018 | Mean Difference (Final Values) | -6.1 | Standard Error of the Mean | 2.5 | 2-Sided | 95 | -11.1 | -1.1 | No | Superiority or Other |
| ANCOVA |
Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable |
| 0.562 |
| Mean Difference (Final Values) |
| -5.3 |
| Standard Error of the Mean |
| 9.2 |
| 2-Sided |
| 95 |
| -23.5 |
| 12.8 |
| No |
| Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable | 0.802 | Mean Difference (Final Values) | 2.3 | Standard Error of the Mean | 9.2 | 2-Sided | 95 | -15.8 | 20.4 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable | 0.772 | Median Difference (Final Values) | 2.6 | Standard Error of the Mean | 9.0 | 2-Sided | 95 | -15.2 | 20.5 | No | Superiority or Other |
| ANCOVA | Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable | 0.409 | Mean Difference (Final Values) | -7.6 | Standard Error of the Mean | 9.2 | 2-Sided | 95 | -25.9 | 10.6 | No | Superiority or Other |