Trial Outcomes & Findings for The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension (NCT NCT01062763)
NCT ID: NCT01062763
Last Updated: 2014-05-08
Results Overview
Change of systolic blood pressure from baseline to study end at four months.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
119 participants
Primary outcome timeframe
4 months
Results posted on
2014-05-08
Participant Flow
Patients recruited from outpatient clinics of endocrinology at two university hospitals and two general hospitals in the period from May 2010 to March 2012.
163 patints screened. 44 screenfailures due to exclusion criteria as indicated. 119 randomized
Participant milestones
| Measure |
Placebo
1tablet of matching placebo trated up to 2 if neccessary
|
Addition of Spironolactone
spironolactone is added to previous antihypertensive treatment
placebo : addition of placebo 1 to 2 tablets daily
spironolactone : 25 to 50 mg once daily
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
61
|
|
Overall Study
COMPLETED
|
55
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Placebo
1tablet of matching placebo trated up to 2 if neccessary
|
Addition of Spironolactone
spironolactone is added to previous antihypertensive treatment
placebo : addition of placebo 1 to 2 tablets daily
spironolactone : 25 to 50 mg once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
Baseline Characteristics
The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension
Baseline characteristics by cohort
| Measure |
Addition of Spironolactone
n=61 Participants
spironolactone is added to previous antihypertensive treatment
placebo : addition of placebo 1 to 2 tablets daily
spironolactone : 25 to 50 mg once daily
|
Placebo
n=58 Participants
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
61 participants
n=5 Participants
|
58 participants
n=7 Participants
|
119 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Analysis by intention to treat using LOCF
Change of systolic blood pressure from baseline to study end at four months.
Outcome measures
| Measure |
Addition of Spironolactone
n=57 Participants
spironolactone is added to previous antihypertensive treatment
spironolactone : 25 uptrated if necessary to 50 mg once daily
|
Placebo
n=55 Participants
1tablet of matching placebo uptrated to 2 if neccessary
|
|---|---|---|
|
Change of of Systolic Blood Pressure
|
-9.6 mm Hg
Interval -12.8 to -6.3
|
-0.7 mm Hg
Interval -3.3 to 2.0
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Analyzed by intention to treat and last observation carried forward
Change of diastolic blood pressure from baseline to study end at four months.
Outcome measures
| Measure |
Addition of Spironolactone
n=57 Participants
spironolactone is added to previous antihypertensive treatment
spironolactone : 25 uptrated if necessary to 50 mg once daily
|
Placebo
n=55 Participants
1tablet of matching placebo uptrated to 2 if neccessary
|
|---|---|---|
|
Change of Diastolic Blood Pressure
|
-3.9 mm Hg
Interval -6.0 to -2.0
|
-0.3 mm Hg
Interval -1.8 to 1.3
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Intention to treat
Outcome measures
| Measure |
Addition of Spironolactone
n=61 Participants
spironolactone is added to previous antihypertensive treatment
spironolactone : 25 uptrated if necessary to 50 mg once daily
|
Placebo
n=58 Participants
1tablet of matching placebo uptrated to 2 if neccessary
|
|---|---|---|
|
Adverse Effects
|
4 participants
|
0 participants
|
Adverse Events
Addition of Spironolactone
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Addition of Spironolactone
n=61 participants at risk
spironolactone is added to previous antihypertensive treatment
spironolactone : 25 uptrated if necessary to 50 mg once daily
|
Placebo
n=58 participants at risk
1tablet of matching placebo uptrated to 2 if neccessary
|
|---|---|---|
|
Blood and lymphatic system disorders
Serious hyperkalemia
|
1.6%
1/61 • Number of events 1 • 4 months
|
0.00%
0/58 • 4 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ib A. Jacobsen
Dept. of Endocrinology, Odense University Hospital
Phone: +45 27203135
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place