Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000722-19 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being conducted to evaluate the effects of Atrasentan on sperm production and testicular function in male subjects with Type 1 or 2 Diabetes and Nephropathy.
This study included 2 periods: a Treatment Period (up to 26 weeks) followed by an Observational Period (up to an additional 52 weeks).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrasentan | Experimental | Atrasentan 0.75 mg administered orally once daily (QD) for 26 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrasentan | Drug | Atrasentan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 | Percentage of Subjects with a Sperm Concentration < 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period. | Up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Entered the Observation Period and Did Not Return to Within 15% of Baseline Sperm Concentration or Above During the 52-Week Observational Period | The percentage of participants who entered the Observational Period and did not return to within 15% of Baseline sperm concentration or above during the 52-week Observational Period. Duplicate semen samples were to be collected during the Observational Period. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance Research Centers /ID# 125945 | Laguna Hills | California | 92653-3621 | United States | ||
| Frank Clark Urology Center /ID# 147794 |
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
The Safety Analysis Set included all enrolled participants who received >= 1 dose of Atrasentan (N = 20); of these 20, 6 participants entered an Observational Period of up to an additional 52 weeks.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Atrasentan | Atrasentan 0.75 mg administered orally once daily (QD). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atrasentan | Atrasentan 0.75 mg administered orally once daily (QD). |
| 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 | Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 | Percentage of Subjects with a Sperm Concentration < 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period. | Evaluable Set: Subjects who met 1 of the following: Study drug compliance ≥ 70%, completed Treatment Period, all planned sperm samples collected; or 2) at least 1 dose study drug, a sperm concentration value that was <15 million/mL observed by the end of the Treatment Period or had a ≥50% reduction from Baseline at the end of the Treatment Period. | Posted | Number | percentage of participants | Up to 26 weeks |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atrasentan | Atrasentan 0.75 mg administered orally once daily (QD). | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2016 | Mar 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2018 | Mar 29, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D003920 | Diabetes Mellitus |
| D003928 | Diabetic Nephropathies |
| D014570 | Urologic Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077868 | Atrasentan |
| ID | Term |
|---|---|
| D052117 | Benzodioxoles |
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 52 weeks after the Treatment Period |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Duplicate semen samples will be collected during the Treatment and Observational Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in sperm concentration. | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a lower sperm motility (worsening). | From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52 |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology | Duplicate semen samples will be collected during the Treatment and Observational Periods. The percentage of sperm with normal versus abnormal morphology will be determined via microscopic analysis. A positive change from baseline indicates an improved sperm morphology. | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume | Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in semen volume. | From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52 |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone | Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum testosterone. | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol | Serum hormones levels were tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum estradiol. | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) | Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum lutenizing hormone. | From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52 |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) | Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum follicle stimulating hormone. | From Week 0 to Treatment Week 26 and Observation Week 52 |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B | Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum Inhibin B. | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 |
| Santa Monica |
| California |
| 90404 |
| United States |
| Research by Design, LLC /ID# 160784 | Evergreen Park | Illinois | 60805 | United States |
| Southern IL Univ School of Med /ID# 129010 | Springfield | Illinois | 62702 | United States |
| Crescent City Clinical Res Ctr /ID# 150989 | Metairie | Louisiana | 70006 | United States |
| Tulane Univ /ID# 130308 | New Orleans | Louisiana | 70112 | United States |
| Albany Medical College /ID# 131068 | Albany | New York | 12208 | United States |
| Urologic Consultants of Southeastern Pennsylvania /ID# 124277 | Bala-Cynwyd | Pennsylvania | 19004-1017 | United States |
| Eastern Virginia Med School /ID# 153740 | Norfolk | Virginia | 23507-1627 | United States |
| Charite Research Organisation GmbH /ID# 154264 | Berlin | 10117 | Germany |
| Ospedale S. Carlo Borromeo /ID# 151672 | Milan | 20153 | Italy |
| SCDU Nefrologia e dialisi-CMID /ID# 151673 | Torino | 10154 | Italy |
| Hospital Universitario Reina S /ID# 151692 | Córdoba | 14004 | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Percentage of Participants Who Entered the Observation Period and Did Not Return to Within 15% of Baseline Sperm Concentration or Above During the 52-Week Observational Period | The percentage of participants who entered the Observational Period and did not return to within 15% of Baseline sperm concentration or above during the 52-week Observational Period. Duplicate semen samples were to be collected during the Observational Period. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period. | Evaluable Set | Posted | Number | percentage of participants | Up to 52 weeks after the Treatment Period |
|
|
|
|
| Secondary | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Duplicate semen samples will be collected during the Treatment and Observational Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in sperm concentration. | All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | Posted | Mean | Standard Deviation | sperm * million per milliliter(X10^6/mL) | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 |
|
|
|
| Secondary | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a lower sperm motility (worsening). | All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | Posted | Mean | Standard Deviation | percent motility | From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52 |
|
|
|
| Secondary | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology | Duplicate semen samples will be collected during the Treatment and Observational Periods. The percentage of sperm with normal versus abnormal morphology will be determined via microscopic analysis. A positive change from baseline indicates an improved sperm morphology. | All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | Posted | Mean | Standard Deviation | percentage of normal | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 |
|
|
|
| Secondary | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume | Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in semen volume. | All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | Posted | Mean | Standard Deviation | milliliter (mL) | From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52 |
|
|
|
| Secondary | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone | Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum testosterone. | All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | Posted | Mean | Standard Deviation | nanomole/liter (nmol/L) | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 |
|
|
|
| Secondary | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol | Serum hormones levels were tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum estradiol. | All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | Posted | Mean | Standard Deviation | Picomoles Per Litre (pmol/L) | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 |
|
|
|
| Secondary | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) | Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum lutenizing hormone. | All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | Posted | Mean | Standard Deviation | International Units/Liter (IU/L) | From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52 |
|
|
|
| Secondary | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) | Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum follicle stimulating hormone. | All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | Posted | Mean | Standard Deviation | International Units/Liter (IU/L) | From Week 0 to Treatment Week 26 and Observation Week 52 |
|
|
|
| Secondary | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B | Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum Inhibin B. | All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 |
|
|
|
| 20 |
| 3 |
| 20 |
| 12 |
| 20 |
| OSTEOMYELITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| POSTOPERATIVE RESPIRATORY FAILURE | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| AORTIC DISSECTION | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| LEFT VENTRICULAR HYPERTROPHY | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| EUSTACHIAN TUBE DYSFUNCTION | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| TOOTH DISORDER | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| LOCALISED INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| TINEA CRURIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| TOOTH INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| CHEST INJURY | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| POST PROCEDURAL INFLAMMATION | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| TOOTH FRACTURE | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| BLOOD PRESSURE INCREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| FLUID OVERLOAD | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| DELIRIUM TREMENS | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| PANIC ATTACK | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| POLLAKIURIA | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| DENTAL PROSTHESIS USER | Social circumstances | MedDRA 21.0 | Systematic Assessment |
|
| AORTIC ANEURYSM | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| HAEMATOMA | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| ORTHOSTATIC HYPERTENSION | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011759 |
| Pyrrolidines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 11.8 |
| 2-Sided |
| 95 |
| 1.5 |
| 36.4 |
| Other |
|
| Observation Period Week 13 |
|
|
| Observation Period Week 26 |
|
|
| Observation Period Week 39 |
|
|
| Observation Period Week 52 |
|
|
|
| Observation Period Week 13 |
|
|
| Observation Period Week 26 |
|
|
| Observation Period Week 39 |
|
|
| Observation Period Week 52 |
|
|
|
| Observation Period Week 13 |
|
|
| Observation Period Week 26 |
|
|
| Observation Period Week 39 |
|
|
| Observation Period Week 52 |
|
|
|
| Observation Period Week 13 |
|
|
| Observation Period Week 26 |
|
|
| Observation Period Week 39 |
|
|
| Observation Period Week 52 |
|
|
|
| Observation Period Week 13 |
|
|
| Observation Period Week 26 |
|
|
| Observation Period Week 39 |
|
|
| Observation Period Week 52 |
|
|
|
| Observation Period Week 13 |
|
|
| Observation Period Week 26 |
|
|
| Observation Period Week 39 |
|
|
| Observation Period Week 52 |
|
|
|
| Observation Period Week 13 |
|
|
| Observation Period Week 26 |
|
|
| Observation Period Week 39 |
|
|
| Observation Period Week 52 |
|
|
|
| Observation Period Week 13 |
|
|
| Observation Period Week 26 |
|
|
| Observation Period Week 39 |
|
|
| Observation Period Week 52 |
|
|
|
| Observation Period Week 13 |
|
|
| Observation Period Week 26 |
|
|
| Observation Period Week 39 |
|
|
| Observation Period Week 52 |
|
|