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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2010/091/000054 | Registry Identifier | Clinical Trials Registry of India |
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| Name | Class |
|---|---|
| Population Health Research Institute | OTHER |
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This is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy tolerability of low strength Polycap versus two doses of low strength Polycap in patients with stable cardiovascular disease in reducing blood pressure and LDL.
To evaluate the tolerability and safety of low dose potassium supplementation compared to placebo in patients with stable cardiovascular disease.
Approximately 500 patients are planned to be randomized.
Mean change in blood pressure between those taking 2capsules of the polycap versus one Difference in Rates of early discontinuation between 2 capsules of polycap versus one Rates of reported adverse effects among those taking the polycap
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SD Polycap without potassium | Active Comparator | Single dose polycap without pottasium |
|
| DD Polycap plus potassium | Experimental | Double Dose polycap with potassium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Dose Polycap | Drug | Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin |
|
| Measure | Description | Time Frame |
|---|---|---|
| BLOOD PRESSURE LIPIDS | Amongst patients with cardiovascular disease or type 2 diabetes, the study aims to test the safety and efficacy of giving double dose of polycap versus a single dose of polycap for 8 weeks; efficacy to lower blood pressure and elevated lipids and safety assessed as difference with tolerance to double dose of polycap compared to a single dose. | 8 weeks |
| Tolerability of a Double Dose of Half Strength Polycap | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics | 8 weeks |
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Inclusion Criteria:
Individuals 40 years and above, with a seated blood pressure > 130/80 mm Hg on two consecutive readings (or BP > 120/80 mm Hg in patients under treatment with 2 or more antihypertensive medication) with one of the following
Those who provide informed consent and can comply with medications and follow-up visits.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr.Prem - Pais, MD | St.Johns Research Institute | Principal Investigator |
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| Label | URL |
|---|---|
| Pubmed Abstract | View source |
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725 Started on Phase 1 run in low dose polycap 645 started on phase 2 run in full dose polycap Only patients who fulfilled >80% compliance to full dose polycap were randomized to the trial
Hospitals in India identified potential consenting eligible subjects with a history of stable cardiovascular disease or high risk for cardiovascular disease and subjected them to an active run in with single dose and then double dose of polycap. Only patients successfully completing the active run in (>80% compliant) were randomized into the trial
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| ID | Title | Description |
|---|---|---|
| FG000 | One Dose of Low Srength Polycap | Patients in this arm will receive one dose of low strength Polycap Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin |
| FG001 | Two Doses of Low Strength Polycap | Patients in this arm will receive 2 doses of low strength Polycap. Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polycap Single Dose | Patients in this arm received single dose of low strength Polycap only Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin |
| BG001 | Polycap Double Dose Plus Potassium |
| 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 | BLOOD PRESSURE LIPIDS | Amongst patients with cardiovascular disease or type 2 diabetes, the study aims to test the safety and efficacy of giving double dose of polycap versus a single dose of polycap for 8 weeks; efficacy to lower blood pressure and elevated lipids and safety assessed as difference with tolerance to double dose of polycap compared to a single dose. | Posted | Mean | 95% Confidence Interval | mmHG | 8 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 | Two Doses of Low Strength Polycap | Patients in this arm will receive 2 doses of low strength Polycap. Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GASTRITIS | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry cough | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alben Sigamani | St John's Research Institute | +918049467080 | alben@sjri.res.in |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D000083242 | Ischemic Stroke |
| D016491 | Peripheral Vascular Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020521 | Stroke |
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| Double dose Polycap | Drug | 2 Capsules of low strength polycap with 30mEq of Potassium |
|
|
Patients in this arm received one dose of low strength Polycap with potassium Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients in this arm will receive one dose of low strength Polycap
Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
|
|
| Primary | Tolerability of a Double Dose of Half Strength Polycap | Not Posted | 8 weeks |
| Secondary | Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics | Not Posted | 8 weeks |
| 9 |
| 257 |
| 5 |
| 257 |
| EG001 | One Dose of Low Srength Polycap | Patients in this arm will receive one dose of low strength Polycap Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin | 1 | 261 | 4 | 261 |
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| D002561 |
| Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |