Trial Outcomes & Findings for INTERVENCION Trial (NCT NCT02373163)
NCT ID: NCT02373163
Last Updated: 2025-07-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
166 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-07-29
Participant Flow
Participant milestones
| Measure |
Diuretic
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
Calcium-channel Blocker
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
|
Angiotensin Receptor Blocker
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
55
|
55
|
|
Overall Study
COMPLETED
|
56
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INTERVENCION Trial
Baseline characteristics by cohort
| Measure |
Diuretic
n=56 Participants
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
Calcium-channel Blocker
n=55 Participants
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
|
Angiotensin Receptor Blocker
n=55 Participants
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
Total
n=166 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Age, Continuous
|
58.32 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
60.95 years
STANDARD_DEVIATION 8.35 • n=7 Participants
|
60.38 years
STANDARD_DEVIATION 8.41 • n=5 Participants
|
59.87 years
STANDARD_DEVIATION 9.00 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Region of Enrollment
Peru
|
56 participants
n=5 Participants
|
55 participants
n=7 Participants
|
55 participants
n=5 Participants
|
166 participants
n=4 Participants
|
|
Systolic blood pressure, office
|
144.68 mm Hg
STANDARD_DEVIATION 9.63 • n=5 Participants
|
143.62 mm Hg
STANDARD_DEVIATION 9.52 • n=7 Participants
|
146.2 mm Hg
STANDARD_DEVIATION 10.59 • n=5 Participants
|
144.83 mm Hg
STANDARD_DEVIATION 9.92 • n=4 Participants
|
|
Diastolic blood pressure, office
|
84.41 mm Hg
STANDARD_DEVIATION 7.27 • n=5 Participants
|
86.7 mm Hg
STANDARD_DEVIATION 12.01 • n=7 Participants
|
86.38 mm Hg
STANDARD_DEVIATION 8.63 • n=5 Participants
|
85.82 mm Hg
STANDARD_DEVIATION 9.50 • n=4 Participants
|
|
24-hour Systolic Blood Pressure
|
127.98 mm Hg
STANDARD_DEVIATION 10.80 • n=5 Participants
|
126.80 mm Hg
STANDARD_DEVIATION 10.65 • n=7 Participants
|
128.40 mm Hg
STANDARD_DEVIATION 14.69 • n=5 Participants
|
127.73 mm Hg
STANDARD_DEVIATION 12.13 • n=4 Participants
|
|
24-hour Diastolic Blood Pressure
|
78.22 mm Hg
STANDARD_DEVIATION 7.90 • n=5 Participants
|
77.43 mm Hg
STANDARD_DEVIATION 9.56 • n=7 Participants
|
78.52 mm Hg
STANDARD_DEVIATION 9.78 • n=5 Participants
|
78.06 mm Hg
STANDARD_DEVIATION 9.07 • n=4 Participants
|
|
24-hour Mean Arterial Pressure
|
101.02 mm Hg
STANDARD_DEVIATION 8.28 • n=5 Participants
|
100.04 mm Hg
STANDARD_DEVIATION 9.29 • n=7 Participants
|
101.37 mm Hg
STANDARD_DEVIATION 10.93 • n=5 Participants
|
100.81 mm Hg
STANDARD_DEVIATION 9.51 • n=4 Participants
|
|
24-hour Pulse Pressure
|
49.76 mm Hg
STANDARD_DEVIATION 8.60 • n=5 Participants
|
49.37 mm Hg
STANDARD_DEVIATION 7.87 • n=7 Participants
|
49.88 mm Hg
STANDARD_DEVIATION 11.15 • n=5 Participants
|
49.67 mm Hg
STANDARD_DEVIATION 9.26 • n=4 Participants
|
|
Carotid Pulse Pressure
|
53.50 mm Hg
n=5 Participants
|
53.00 mm Hg
n=7 Participants
|
55.00 mm Hg
n=5 Participants
|
54.00 mm Hg
n=4 Participants
|
|
Carotid-Femoral Pulse Wave Velocity
|
8.70 meters/second
n=5 Participants
|
8.20 meters/second
n=7 Participants
|
8.35 meters/second
n=5 Participants
|
8.40 meters/second
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Diuretic
n=56 Participants
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
Calcium-channel Blocker
n=55 Participants
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
|
Angiotensin Receptor Blocker
n=55 Participants
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
|---|---|---|---|
|
Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks
|
-5.9 mmHg
Standard Deviation 8.4
|
-7.5 mmHg
Standard Deviation 9.2
|
-8.4 mmHg
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Diuretic
n=56 Participants
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
Calcium-channel Blocker
n=55 Participants
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
|
Angiotensin Receptor Blocker
n=55 Participants
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
|---|---|---|---|
|
Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks
|
-3.5 mmHg
Standard Deviation 5.7
|
-4.7 mmHg
Standard Deviation 5.5
|
-5.6 mmHg
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Diuretic
n=56 Participants
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
Calcium-channel Blocker
n=55 Participants
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
|
Angiotensin Receptor Blocker
n=55 Participants
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
|---|---|---|---|
|
Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks
|
-4.6 mmHg
Standard Deviation 6.5
|
-6.0 mmHg
Standard Deviation 6.9
|
-6.9 mmHg
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Diuretic
n=56 Participants
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
Calcium-channel Blocker
n=55 Participants
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
|
Angiotensin Receptor Blocker
n=55 Participants
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
|---|---|---|---|
|
Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks
|
-2.4 mmHg
Standard Deviation 5.4
|
-2.8 mmHg
Standard Deviation 5.6
|
-2.8 mmHg
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Diuretic
n=56 Participants
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
Calcium-channel Blocker
n=55 Participants
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
|
Angiotensin Receptor Blocker
n=55 Participants
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
|---|---|---|---|
|
Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks
|
-11.6 mmHg
Standard Deviation 15.6
|
-9.6 mmHg
Standard Deviation 18.7
|
-11.2 mmHg
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Diuretic
n=56 Participants
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
Calcium-channel Blocker
n=55 Participants
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
|
Angiotensin Receptor Blocker
n=55 Participants
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
|
|---|---|---|---|
|
Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks
|
-0.4 m/sec
Standard Deviation 1.3
|
-0.3 m/sec
Standard Deviation 1.3
|
-0.6 m/sec
Standard Deviation 2.0
|
Adverse Events
Diuretic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Calcium-channel Blocker
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Angiotensin Receptor Blocker
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place