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This trial is designed to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diuretic | Active Comparator | Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM |
|
| Calcium-channel blocker | Active Comparator | Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM |
|
| Angiotensin Receptor Blocker | Active Comparator | Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrochlorothiazide | Drug | Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM |
| Measure | Description | Time Frame |
|---|---|---|
| Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks | 4 weeks | |
| Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks | 4 weeks | |
| Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigacion PREVENCION | Arequipa | AQP | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20409853 | Background | Medina-Lezama J, Zea-Diaz H, Morey-Vargas OL, Bolanos-Salazar JF, Postigo-Macdowall M, Paredes-Diaz S, Corrales-Medina F, Valdivia-Ascuna Z, Cuba-Bustinza C, Villalobos-Tapia P, Munoz-Atahualpa E, Chirinos-Pacheco J, Raij L, Chirinos JA. Prevalence and patterns of hypertension in Peruvian Andean Hispanics: the PREVENCION study. J Am Soc Hypertens. 2007 May-Jun;1(3):216-25. doi: 10.1016/j.jash.2007.02.003. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diuretic | Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM |
| FG001 | Calcium-channel Blocker | Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM |
| FG002 | Angiotensin Receptor Blocker | Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diuretic | Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM |
| 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 |
| 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 is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks | Posted | Mean | Standard Deviation | mmHg | 4 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 | Diuretic | Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josefina Medina-Lezama | PREVENCION | +5154251269 | jmedinal2911@gmail.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| D017311 | Amlodipine |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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|
|
| Amlodipine | Drug | Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM |
|
| Telmisartan | Drug | Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM |
|
| 4 weeks |
| Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks | 4 weeks |
| Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks | 4 weeks |
| BG001 | Calcium-channel Blocker | Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM |
| BG002 | Angiotensin Receptor Blocker | Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Systolic blood pressure, office | Mean | Standard Deviation | mm Hg |
|
| Diastolic blood pressure, office | Mean | Standard Deviation | mm Hg |
|
| 24-hour Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| 24-hour Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| 24-hour Mean Arterial Pressure | Mean | Standard Deviation | mm Hg |
|
| 24-hour Pulse Pressure | Mean | Standard Deviation | mm Hg |
|
| Carotid Pulse Pressure | Mean | Inter-Quartile Range | mm Hg |
|
| Carotid-Femoral Pulse Wave Velocity | Mean | Inter-Quartile Range | meters/second |
|
| OG002 | Angiotensin Receptor Blocker | Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM |
|
|
| Secondary | Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
|
| Secondary | Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
|
| Secondary | Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
|
| Secondary | Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
|
| Secondary | Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks | Posted | Mean | Standard Deviation | m/sec | 4 weeks |
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Calcium-channel Blocker | Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM | 0 | 55 | 0 | 55 |
| EG002 | Angiotensin Receptor Blocker | Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM | 0 | 55 | 0 | 55 |
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| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |