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Trial Outcomes & Findings for Nesiritide in Resistant Hypertension (NCT NCT01514357)

NCT ID: NCT01514357

Last Updated: 2018-03-23

Results Overview

The change in BP with treatment over 7 days was assessed by the mean BP on admission, (treatment day 1) mean BP 23 hours after the first injection of BNP, and mean BP 23 hours after the second injection of BNP (treatment day 2). Treatment day 2 was 7 days after admission.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

baseline, treatment day 1, treatment day 2

Results posted on

2018-03-23

Participant Flow

Subjects were recruited at Mayo Clinic in Rochester, Minnesota.

Participant milestones

Participant milestones
Measure
Nesiritide (BNP)
Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
Placebo
Subjects will receive SQ placebo bid for seven consecutive days.
Overall Study
STARTED
12
0
Overall Study
COMPLETED
8
0
Overall Study
NOT COMPLETED
4
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Nesiritide (BNP)
Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
Placebo
Subjects will receive SQ placebo bid for seven consecutive days.
Overall Study
Screen failure
2
0
Overall Study
Withdrawal by Subject
2
0

Baseline Characteristics

Nesiritide in Resistant Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nesiritide (BNP)
n=12 Participants
Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
Placebo
Subjects will receive SQ placebo bid for seven consecutive days.
Total
n=12 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
12 Participants
n=5 Participants
0 Participants
n=7 Participants
12 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
0 Participants
n=7 Participants
7 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
0 Participants
n=7 Participants
5 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants
—
12 participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline, treatment day 1, treatment day 2

The change in BP with treatment over 7 days was assessed by the mean BP on admission, (treatment day 1) mean BP 23 hours after the first injection of BNP, and mean BP 23 hours after the second injection of BNP (treatment day 2). Treatment day 2 was 7 days after admission.

Outcome measures

Outcome measures
Measure
Nesiritide (BNP)
n=8 Participants
Subjects will receive subcutaneous (SQ) Nesiritide (BNP) bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
Placebo
Subjects will receive SQ placebo bid for seven consecutive days.
Changes in Systolic Blood Pressure (BP)
Baseline
153 mmHg
Standard Deviation 9.180
—
Changes in Systolic Blood Pressure (BP)
Treatment Day 1
134 mmHg
Standard Deviation 9.07
—
Changes in Systolic Blood Pressure (BP)
Treatment Day 2
129 mmHg
Standard Deviation 17.34
—

Adverse Events

Nesiritide (BNP)

Serious events: 0 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

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John C. Burnett

Mayo Clinic

Phone: 507-284-7932

Results disclosure agreements

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