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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_015 |
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The primary objective of this study is to evaluate efficacy, arterial stiffness measured by Pulse Wave Velocity (PWV) of Losartan potassium group compared to Carvedilol group after 24 weeks of treatment in patients with the essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Losartan or Losartan/HCTZ |
|
| 2 | Active Comparator | Carvedilol or Carvedilol/HCTZ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| losartan potassium | Drug | Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Analysis was performed in the modified intention to treat (mITT) population. | Baseline and 24 Weeks |
| PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan. | Baseline and 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Baseline and 24 weeks | |
| Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug |
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Inclusion Criteria:
If diabetes patients, mean SBP ≥ 130 mm Hg or mean DBP ≥ 80 mm Hg (Mean of blood pressure values measured consecutively at least 2 minutes apart)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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7 centers participated in this study (7 medical centers of university).
FPE (First patient enrolled): Feb-2008, FPI (First patient in): Feb-2008, LPO (Last patient out): Sep-2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan | Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan). |
| FG001 | Carvedilol | Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan | Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan). |
| 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 | Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Analysis was performed in the modified intention to treat (mITT) population. | Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94). Missing data were imputed by the last observation carried forward (LOCF) technique. | Posted | Mean | Standard Deviation | meters/second | Baseline and 24 Weeks |
|
Adverse events were recorded from first administration of study drug up to 14 days after the administration of final dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Losartan | Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelitis transverse | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (Unspecified) | 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 |
|---|---|
| D019808 | Losartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Comparator: carvedilol | Drug | Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) |
|
| Comparator: losartan (+) hydrochlorothiazide (HCTZ) | Drug | Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) |
|
| Comparator: carvedilol (+) hydrochlorothiazide | Drug | Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) |
|
| Baseline and 24 weeks |
| Inclusion/exclusion criteria not met |
|
| Adverse Event |
|
| IP administration violation |
|
| Lost to Follow-up |
|
| Blood Pressure control failure |
|
| BG001 |
| Carvedilol |
Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| DBP (diastolic blood pressure) | Mean | Standard Deviation | mm Hg |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| PWV (pulse wave velocity) | Mean | Standard Deviation | meters/second |
|
| Pulse | Mean | Standard Deviation | BPM (beats per minute) |
|
| SBP (systolic blood pressure) | Mean | Standard Deviation | mm Hg |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| OG001 | Carvedilol | Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation. |
|
|
|
| Primary | PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan. | Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). Missing data were imputed by the last observation carried forward (LOCF) technique. For the primary efficacy endpoints, Per protocol analysis approach was supplementary used. | Posted | Mean | Standard Deviation | meters/second | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 24 weeks |
|
|
|
|
| Secondary | Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 24 weeks |
|
|
|
|
| 5 |
| 101 |
| 35 |
| 101 |
| EG001 | Carvedilol | Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once. | 6 | 100 | 51 | 100 |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Reflux gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Benign colonic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |