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Trial Outcomes & Findings for Study 1: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients (NCT NCT02133872)

NCT ID: NCT02133872

Last Updated: 2025-10-23

Results Overview

The primary measure of interest was the categorical classification of subjects into responders vs. non-responders upon treatment with a specific minocycline dose: 50, 100 or 200 mg/d. Responders are defined as subjects who achieve a drop of \>5 mmHg in mean daytime SBP, based on daytime ABPM measurements (7 am to 10 pm). For these participants, the discontinuation or lowering of the dose of a concurrent anti-hypertensive drug due to excessive SBP reduction will also be assessed. Excessive SBP reduction is defined as an office SBP \<120 mmHg or \>10 mmHg SBP decrease associated with symptom(s). On the other hand, non-responders are defined as the participants that fail to show any change in their average daytime SBP measured through ABPM despite being exposed to the different minocycline doses evaluated.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

180 days

Results posted on

2025-10-23

Participant Flow

Open-label design of dose titration. Subjects will receive minocycline 50mg if no mean daytime ABPM SBP decline =/\> 5mm Hg; subjects will receive minocycline 100mg, if no mean daytime ABPM SBP decline =/\> 5mm Hg BP subjects will receive minocycline 200 mg.

Participant milestones

Participant milestones
Measure
MInocycline (50 mg/d)
Subjects received minocycline 50mg/d.
Minocycline (100 mg/d)
Subjects received minocycline 50mg escalated to 100 mg/d.
Minocycline (200 mg/d)
Subjects received minocycline 50mg escalating to 100 mg then 200 mg/d.
Overall Study
STARTED
15
5
14
Overall Study
COMPLETED
10
2
14
Overall Study
NOT COMPLETED
5
3
0

Reasons for withdrawal

Reasons for withdrawal
Measure
MInocycline (50 mg/d)
Subjects received minocycline 50mg/d.
Minocycline (100 mg/d)
Subjects received minocycline 50mg escalated to 100 mg/d.
Minocycline (200 mg/d)
Subjects received minocycline 50mg escalating to 100 mg then 200 mg/d.
Overall Study
Withdrawal by Subject
5
3
0

Baseline Characteristics

Study 1: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Minocycline Dose Escalation
n=34 Participants
The total population of subject in the Minocycline Dose Escalation is 34. Non-Responders of 50 mg/d continued to 100 mg/d. Non-responders of 100 mg/d continued to 200 mg/d.
Age, Continuous
64.06 years
STANDARD_DEVIATION 8.74 • n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
18 Participants
n=5 Participants
Race (NIH/OMB)
White
15 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Region of Enrollment
United States
34 participants
n=5 Participants
Baseline office SBP
140 mmHg
STANDARD_DEVIATION 14 • n=5 Participants

PRIMARY outcome

Timeframe: 180 days

The primary measure of interest was the categorical classification of subjects into responders vs. non-responders upon treatment with a specific minocycline dose: 50, 100 or 200 mg/d. Responders are defined as subjects who achieve a drop of \>5 mmHg in mean daytime SBP, based on daytime ABPM measurements (7 am to 10 pm). For these participants, the discontinuation or lowering of the dose of a concurrent anti-hypertensive drug due to excessive SBP reduction will also be assessed. Excessive SBP reduction is defined as an office SBP \<120 mmHg or \>10 mmHg SBP decrease associated with symptom(s). On the other hand, non-responders are defined as the participants that fail to show any change in their average daytime SBP measured through ABPM despite being exposed to the different minocycline doses evaluated.

Outcome measures

Outcome measures
Measure
Minocycline (50 mg/d)
n=34 Participants
Subjects received minocycline 50mg/d.
Minocycline (100 mg/d)
n=19 Participants
Subjects received minocycline 50mg escalating to 100 mg/d.
Minocycline (200 mg/d)
n=14 Participants
Subjects received minocycline 50mg escalating to 100 mg then 200 mg/d.
Categorical Classification of Subjects Into Responders vs. Non-responders
Responders
10 Participants
2 Participants
4 Participants
Categorical Classification of Subjects Into Responders vs. Non-responders
Non-responders
19 Participants
14 Participants
10 Participants
Categorical Classification of Subjects Into Responders vs. Non-responders
Participants who withdrew from study
5 Participants
3 Participants
0 Participants

SECONDARY outcome

Timeframe: 180 days

Among Responders, difference in overall daytime and nighttime Systolic Blood Pressure (SBP) using 24 hour Ambulatory Blood Pressure Monitoring (ABPM) from baseline to final visit

Outcome measures

Outcome measures
Measure
Minocycline (50 mg/d)
n=10 Participants
Subjects received minocycline 50mg/d.
Minocycline (100 mg/d)
n=2 Participants
Subjects received minocycline 50mg escalating to 100 mg/d.
Minocycline (200 mg/d)
n=4 Participants
Subjects received minocycline 50mg escalating to 100 mg then 200 mg/d.
Change in 24 Hour SBP by ABPM
4 mmHg
Standard Deviation 12
4 mmHg
Standard Deviation 3
16 mmHg
Standard Deviation 3

SECONDARY outcome

Timeframe: 180 days

Among Responders, evaluation of changes in office systolic blood pressure (SBP) from baseline to final visit

Outcome measures

Outcome measures
Measure
Minocycline (50 mg/d)
n=10 Participants
Subjects received minocycline 50mg/d.
Minocycline (100 mg/d)
n=2 Participants
Subjects received minocycline 50mg escalating to 100 mg/d.
Minocycline (200 mg/d)
n=4 Participants
Subjects received minocycline 50mg escalating to 100 mg then 200 mg/d.
Changes in Office SBP Over Time
13 mmHg
Standard Deviation 10
2 mmHg
Standard Deviation 1
20 mmHg
Standard Deviation 16

Adverse Events

Minocycline (50 mg/d)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Minocycline (100 mg/d)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Minocycline (200 mg/d)

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
Minocycline (50 mg/d)
n=15 participants at risk
Subjects received minocycline 50mg/d.
Minocycline (100 mg/d)
n=5 participants at risk
Subjects received minocycline 50mg escalating to 100 mg/d.
Minocycline (200 mg/d)
n=14 participants at risk
Subjects received minocycline 50mg escalating to 100 mg then 200 mg/d.
Vascular disorders
Asymptomatic hypotension
20.0%
3/15 • Number of events 3 • 180 days - from baseline to final visit
40.0%
2/5 • Number of events 2 • 180 days - from baseline to final visit
0.00%
0/14 • 180 days - from baseline to final visit

Additional Information

Dr. Carl J. Pepine

University of Florida

Phone: (352) 339-0696

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place