Trial Outcomes & Findings for Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium (NCT NCT01404078)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

518 participants

Primary outcome timeframe

8 weeks

Results posted on

2014-12-01

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	261	257
Overall Study COMPLETED	243	237
Overall Study NOT COMPLETED	18	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polycap Single Dose n=257 Participants 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	Polycap Double Dose Plus Potassium n=261 Participants 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	Total n=518 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 19.4 • n=5 Participants	57.9 years STANDARD_DEVIATION 19.2 • n=7 Participants	57.6 years STANDARD_DEVIATION 19.5 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	108 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Male	154 Participants n=5 Participants	153 Participants n=7 Participants	307 Participants n=5 Participants
Region of Enrollment India	257 participants n=5 Participants	261 participants n=7 Participants	518 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Two Doses of Low Strength Polycap n=257 Participants 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	One Dose of Low Srength Polycap n=261 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
BLOOD PRESSURE LIPIDS	126.6 mmHG Interval 122.4 to 132.6	129.9 mmHG Interval 127.5 to 131.6

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

Adverse Events

Two Doses of Low Strength Polycap

Serious events: 9 serious events

Other events: 5 other events

Deaths: 0 deaths

One Dose of Low Srength Polycap

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Two Doses of Low Strength Polycap n=257 participants at risk 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	One Dose of Low Srength Polycap n=261 participants at risk 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
Gastrointestinal disorders GASTRITIS	3.5% 9/257 • Number of events 9	0.38% 1/261 • Number of events 1

Other adverse events

Other adverse events
Measure	Two Doses of Low Strength Polycap n=257 participants at risk 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	One Dose of Low Srength Polycap n=261 participants at risk 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
Respiratory, thoracic and mediastinal disorders Dry cough	1.9% 5/257 • Number of events 5	1.5% 4/261 • Number of events 4

Additional Information

Dr. Alben Sigamani

St John's Research Institute

Phone: +918049467080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place