| Trial ID: | L6552 |
| Source ID: | NCT01404078
|
| Associated Drug: |
Single Dose Polycap
|
| Title: |
Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium
|
| Acronym: |
TIPSK
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01404078/results
|
| Conditions: |
Ischemic Heart Disease|Ischemic Stroke|Peripheral Vascular Disease|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Single Dose Polycap|DRUG: Double dose Polycap
|
| Outcome Measures: |
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., 8 weeks|Tolerability of a Double Dose of Half Strength Polycap, 8 weeks | Secondary: Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics, 8 weeks
|
| Sponsor/Collaborators: |
Sponsor: St. John's Research Institute | Collaborators: Population Health Research Institute
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
518
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-04
|
| Completion Date: |
2011-02
|
| Results First Posted: |
2014-12-01
|
| Last Update Posted: |
2014-12-01
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01404078
|
