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This study aims to evaluate the efficacy and safety of the coadministration of valsartan (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered alone in patients with hypertension and hyperlipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan 160mg, Rosuvastatin 20mg | Experimental | Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks. |
|
| Valsartan 160mg, Rosuvastatin 20mg placebo | Active Comparator | Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. |
|
| Valsartan 160mg placebo, Rosuvastatin 20mg | Active Comparator | Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks. |
|
| Placebo | Placebo Comparator | Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan 160mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| sitDBP Changes at Week 8 From Baseline | sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline | 8 weeks |
| LDL-C Percentage Changes at Week 8 From Baseline | LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System Severance Hospital | Seoul | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valsartan 160mg, Rosuvastatin 20mg | Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks. Valsartan 160mg Rosuvastatin 20mg |
| FG001 | Valsartan 160mg, Rosuvastatin 20mg Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rosuvastatin 20mg | Drug |
|
|
| Valsartan 160mg placebo | Drug |
|
| Rosuvastatin 20mg placebo | Drug |
|
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg placebo
| FG002 | Valsartan 160mg Placebo, Rosuvastatin 20mg | Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks. Rosuvastatin 20mg Valsartan 160mg placebo |
| FG003 | Placebo | Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. Valsartan 160mg placebo Rosuvastatin 20mg placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Valsartan 160mg, Rosuvastatin 20mg | Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks. Valsartan 160mg Rosuvastatin 20mg |
| BG001 | Valsartan 160mg, Rosuvastatin 20mg Placebo | Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. Valsartan 160mg Rosuvastatin 20mg placebo |
| BG002 | Valsartan 160mg Placebo, Rosuvastatin 20mg | Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks. Rosuvastatin 20mg Valsartan 160mg placebo |
| BG003 | Placebo | Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. Valsartan 160mg placebo Rosuvastatin 20mg placebo |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | sitDBP Changes at Week 8 From Baseline | sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline | FAS | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | 8 weeks |
|
|
| ||||||||||||||||||||||||||||
| Primary | LDL-C Percentage Changes at Week 8 From Baseline | LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline | FAS | Posted | Least Squares Mean | 95% Confidence Interval | percent change | 8 weeks |
|
|
12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests .
The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
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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 | Valsartan 160mg, Rosuvastatin 20mg | Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks. Valsartan 160mg Rosuvastatin 20mg | 1 | 43 | 10 | 43 | ||
| EG001 | Valsartan 160mg, Rosuvastatin 20mg Placebo | Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. Valsartan 160mg Rosuvastatin 20mg placebo | 0 | 41 | 7 | 41 | ||
| EG002 | Valsartan 160mg Placebo, Rosuvastatin 20mg | Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks. Rosuvastatin 20mg Valsartan 160mg placebo | 0 | 37 | 4 | 37 | ||
| EG003 | Placebo | Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. Valsartan 160mg placebo Rosuvastatin 20mg placebo | 0 | 45 | 5 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment | The subject participated in the study on 17 Sep 2012, and she was randomized on 18 Oct 2012. On that day, the subject had nausea and chest pain after eating cake, and visited the institution and was hospitalized on 22 Oct 2012. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| conjunctival haemorrhage | Eye disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| dyspepsia | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| nasopharyngisit | Infections and infestations | MedDRA version 15.1 | Non-systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| asthenia | General disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| chest discomfort | General disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| chest pain | General disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| face oedema | General disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| oedema peripheral | General disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA version 15.1 | Non-systematic Assessment |
| |
| contusion | Injury, poisoning and procedural complications | MedDRA version 15.1 | Non-systematic Assessment |
| |
| alanine aminotransferase increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
| |
| aspartate aminotransferase increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
| |
| blood creatine phosphokinase increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
| |
| blood potassium increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
| |
| gamma-glutamyltransferase increased | Investigations | MedDRA version 15.1 | Non-systematic Assessment |
| |
| musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| hypoaesthesia | Nervous system disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA version 15.1 | Non-systematic Assessment |
| |
| upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
|
Withdrawal(discontinuation) leading to smaller number of per-protocol set than full analysis set. The violation of protocol was the criterion of subjects' withdrawal.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. YangSoo Jang | Yonsei University Healthcare System Severance Hospital | 82-2-6924-3109 | yejung@lgls.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|