Trial · NCT01404078
Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium
NCT01404078, Not applicable, Completed, St. John's Research Institute; results first posted 2014-12-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium. Trials, record NCT01404078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01404078
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium
- NCT number
- NCT01404078
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 518 participants, actual
- Lead sponsor
- St. John's Research Institute
- Conditions
- Ischemic Heart Disease, Ischemic Stroke, Peripheral Vascular Disease, Type 2 Diabetes Mellitus
- Interventions
- Single Dose Polycap, Double dose Polycap
- First posted
- 2011-07-27
- Last updated
- 2014-12-01
- Results first posted
- 2014-12-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | BLOOD PRESSURE LIPIDS | 8 weeks | 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. |
| Primary | Tolerability of a Double Dose of Half Strength Polycap | 8 weeks | |
| Secondary | Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics | 8 weeks |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | BLOOD PRESSURE LIPIDS | 8 weeks | mmHG | MEAN | |
| PRIMARY | Tolerability of a Double Dose of Half Strength Polycap | 8 weeks | |||
| SECONDARY | Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics | 8 weeks |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| BLOOD PRESSURE LIPIDS | Two Doses of Low Strength Polycap | 126.6 | 95% Confidence Interval 122.4 to 132.6 | mmHG | |
| BLOOD PRESSURE LIPIDS | One Dose of Low Srength Polycap | 129.9 | 95% Confidence Interval 127.5 to 131.6 | mmHG |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | One Dose of Low Srength Polycap | 261 | |
| Overall Study | STARTED | Two Doses of Low Strength Polycap | 257 | |
| Overall Study | COMPLETED | One Dose of Low Srength Polycap | 243 | |
| Overall Study | COMPLETED | Two Doses of Low Strength Polycap | 237 | |
| Overall Study | NOT COMPLETED | One Dose of Low Srength Polycap | 18 | |
| Overall Study | NOT COMPLETED | Two Doses of Low Strength Polycap | 20 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry cough | Respiratory, thoracic and mediastinal disorders | Two Doses of Low Strength Polycap | 5 | 257 | 5 |
| other | Dry cough | Respiratory, thoracic and mediastinal disorders | One Dose of Low Srength Polycap | 4 | 261 | 4 |
| serious | GASTRITIS | Gastrointestinal disorders | Two Doses of Low Strength Polycap | 9 | 257 | 9 |
| serious | GASTRITIS | Gastrointestinal disorders | One Dose of Low Srength Polycap | 1 | 261 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Two Doses of Low Strength Polycap | ||
| Total, all-cause mortality | One Dose of Low Srength Polycap | ||
| Total, other adverse events | Two Doses of Low Strength Polycap | 5 | 257 |
| Total, other adverse events | One Dose of Low Srength Polycap | 4 | 261 |
| Total, serious adverse events | Two Doses of Low Strength Polycap | 9 | 257 |
| Total, serious adverse events | One Dose of Low Srength Polycap | 1 | 261 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Two Doses of Low Strength Polycap vs One Dose of Low Srength Polycap: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01404078
GET https://conductscience.org/api/trials/v1/NCT01404078/registered