Trial Outcomes & Findings for Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants (NCT NCT01037530)

Results Overview

The primary outcome measure for this trial is the Maximum Walking Distance (MWD). Treadmill exercise test will be used to estimate the maximum distance the participant can walk at a speed of 2.5 km/h with a 10

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

Baseline

Results posted on

2025-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Ramipril Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks	Placebo Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks
Overall Study STARTED	14	19
Overall Study COMPLETED	12	17
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramipril n=14 Participants Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks	Placebo n=19 Participants Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks	Total n=33 Participants Total of all reporting groups
Age, Continuous	64.4 Years STANDARD_DEVIATION 8.2 • n=47 Participants	64.7 Years STANDARD_DEVIATION 7.7 • n=41 Participants	64.55 Years STANDARD_DEVIATION 7.82 • n=88 Participants
Sex: Female, Male Female	3 Participants n=47 Participants	5 Participants n=41 Participants	8 Participants n=88 Participants
Sex: Female, Male Male	11 Participants n=47 Participants	14 Participants n=41 Participants	25 Participants n=88 Participants

PRIMARY outcome

Timeframe: Baseline

The primary outcome measure for this trial is the Maximum Walking Distance (MWD). Treadmill exercise test will be used to estimate the maximum distance the participant can walk at a speed of 2.5 km/h with a 10

Outcome measures

Outcome measures
Measure	Ramipril n=14 Participants Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks	Placebo n=19 Participants Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks
Maximum Walking Distance (MWD).	137 Metres Interval 110.0 to 213.0	143 Metres Interval 72.0 to 213.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0,2,6,24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0,2,6,24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0,2,6,24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0,2,6,24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome data not reported

Adverse Events

Ramipril

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ramipril n=14 participants at risk Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks	Placebo n=19 participants at risk Ramipril: 5 mg/day for 2 weeks then 10 mg/day for 22 weeks
Cardiac disorders Cough	28.6% 4/14 • Number of events 4	0.00% 0/19
General disorders Dizziness	7.1% 1/14 • Number of events 1	0.00% 0/19
Endocrine disorders Hyperkalaemia	7.1% 1/14 • Number of events 1	0.00% 0/19

Additional Information

Judith Long

Hull University Teaching Hospitals NHS Trust

Phone: 01482 311918

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place