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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy and safety of this combination in a Russian population of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Single arm study of combivir and maraviroc for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV therapy | Drug | Combivir one tablet BD with maraviroc 300mg BD for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks. | Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits. | Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders. | Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Center on AIDS and Infectious Diseases Prophylaxis and Control | Krasnoyarsk | 660049 | Russia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34160290 | Derived | Lewis ME, Jubb B, Simpson P, Lopatukhin A, Kireev D, Bobkova M, Craig C, van der Ryst E, Westby M, Butler SL. Highly prevalent Russian HIV-1 V3-loop sequence variants are susceptible to maraviroc. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211025156. doi: 10.1177/20402066211025156. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Treatment naïve Human Immuno Deficiency Virus (HIV) infected participants aged 18 years at screening were enrolled. Participants were required to meet all eligibility criteria prior to randomization into the study.
This report presents results of a 48 week study conducted at 8 centers in Russia. A total of 98 subjects were enrolled in the study; however, one site was closed and data from this site was deemed unusable, thus in total 77 subjects were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maraviroc+Combivir | All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Maraviroc+Combivir | All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg) |
| 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 Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks. | Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders. | Full Analysis Set (FAS) Population included those participants who had taken at least 1 dose of the study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | 48 weeks |
|
Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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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 | Maraviroc+Combivir | All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits. | Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders. | Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48 |
| Virologic Response: Rate of Virologic Failure at Week 48. | Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Participants with Time to loss of virologic response (defined by level of <50 copies/mL) failure were classified as rebounders or non-responders. | 48 weeks |
| Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) | Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count | Week 48 |
| Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) | Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count | Week 48 |
| Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8) | Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count. | Week 48 |
| Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8) | Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count. | Week 48 |
| Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio. | Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio. | Week 48 |
| Number of Participants With Genotypic Resistance. | The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes. | Screening to Week 48 or Time of treatment Failure |
| Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure. | Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load > 400 copies/mL only). | Screening to Week 48 or Time of treatment Failure |
| Federal scientific and methodological center on AIDS prophylaxis and control |
| Moscow |
| 105275 |
| Russia |
| Moscow regional center on AIDS and infectious diseases prophylaxis and control | Moscow | 129110 | Russia |
| Regional Center on AIDS and Infectious Diseases Prophylaxis and Control | Nizhny Novgorod | 603005 | Russia |
| Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control | Saint Petersburg | 190103 | Russia |
| Federal State Institution Republican clinical infectious hospital of Roszdrav | Saint Petersburg | 196645 | Russia |
| Smolensk Center on AIDS and infectious diseases prophylaxis and control | Smolensk | 214006 | Russia |
| Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control | Volgograd | 400040 | Russia |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Adverse Event |
|
| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits. | Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders. | FAS Population included those participants who had taken at least 1 dose of the study drug. | Posted | Number | Percentage of participants | Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48 |
|
|
|
| Secondary | Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits. | Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders. | FAS Population included those participants who had taken at least 1 dose of the study drug. | Posted | Number | Percentage of participants | Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48 |
|
|
|
| Secondary | Virologic Response: Rate of Virologic Failure at Week 48. | Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Participants with Time to loss of virologic response (defined by level of <50 copies/mL) failure were classified as rebounders or non-responders. | FAS Population included those participants who had taken at least 1 dose of the study drug. | Posted | Number | Participants | 48 weeks |
|
|
|
| Secondary | Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) | Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count | FAS Population included those participants who had taken at least 1 dose of the study drug. | Posted | Mean | Standard Deviation | cells/microliter (cells/mcL) | Week 48 |
|
|
|
| Secondary | Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) | Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count | FAS Population included those participants who had taken at least 1 dose of the study drug. | Posted | Mean | Standard Deviation | Percent | Week 48 |
|
|
|
| Secondary | Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8) | Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count. | FAS Population included those participants who had taken at least 1 dose of the study drug. | Posted | Mean | Standard Deviation | cells/mcL | Week 48 |
|
|
|
| Secondary | Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8) | Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count. | FAS Population included those participants who had taken at least 1 dose of the study drug. | Posted | Mean | Standard Deviation | Percent | Week 48 |
|
|
|
| Secondary | Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio. | Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio. | FAS Population included those participants who had taken at least 1 dose of the study drug. | Posted | Mean | Standard Deviation | Ratio | Week 48 |
|
|
|
| Secondary | Number of Participants With Genotypic Resistance. | The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes. | All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis. | Posted | Number | Participants | Screening to Week 48 or Time of treatment Failure |
|
|
|
| Secondary | Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure. | Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load > 400 copies/mL only). | All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis. | Posted | Number | Participants | Screening to Week 48 or Time of treatment Failure |
|
|
|
| 2 |
| 77 |
| 51 |
| 77 |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Salpingo-oophoritis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Vaginitis bacterial | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Viral rhinitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Neuritis cranial | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Drug dependence | Psychiatric disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Nail psoriasis | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Cows milk free diet | Surgical and medical procedures | MedDRA v15.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRAV15.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRAV15.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRAV15.1 | Non-systematic Assessment |
|
| Amylase increased | Investigations | MedDRAV15.1 | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRAV15.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRAV15.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRAV15.1 | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRAV15.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRAV15.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRAV15.1 | Non-systematic Assessment |
|
| Essential hypertension | Vascular disorders | MedDRAV15.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRAV15.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Week 12 (N= 76) |
|
| Week 20 (N= 73) |
|
| Week 24 (N= 73) |
|
| Week 36 (N= 68) |
|
| Week 48 (N= 65) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (N= 76) |
|
| Week 20 (N= 73) |
|
| Week 24 (N= 73) |
|
| Week 36 (N= 68) |
|
| Week 48 (N= 65) |
|
| Title | Measurements |
|---|---|
|
| Death |
|
| Discontinued before Week 48 due to Adverse Events |
|
| Discontinued before Week 48 for other reasons |
|