Trial Outcomes & Findings for Combined Renin Inhibition/Beta-blockade (NCT NCT00627861)
NCT ID: NCT00627861
Last Updated: 2015-11-24
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
5th, 6th, 7th, 9th, 10th, 11th, 12th weeks
Results posted on
2015-11-24
Participant Flow
Participant milestones
| Measure |
Aliskiren and Metoprolol
Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combined Renin Inhibition/Beta-blockade
Baseline characteristics by cohort
| Measure |
Aliskiren and Metoprolol
n=1 Participants
Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5th, 6th, 7th, 9th, 10th, 11th, 12th weeksOutcome measures
| Measure |
Aliskiren and Metoprolol
n=1 Participants
Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
|
|---|---|
|
Plasma Renin Concentration
Week 5
|
16.5 pg/mL
|
|
Plasma Renin Concentration
Week 6
|
13.5 pg/mL
|
|
Plasma Renin Concentration
Week 7
|
20.5 pg/mL
|
|
Plasma Renin Concentration
Week 9
|
22 pg/mL
|
|
Plasma Renin Concentration
Week 10
|
2.7 pg/mL
|
|
Plasma Renin Concentration
Week 11
|
4.4 pg/mL
|
|
Plasma Renin Concentration
Week 12
|
3.2 pg/mL
|
SECONDARY outcome
Timeframe: screening, 4th, 6th, 7th, 9th, 10th, 11th, 12th weeksThe blood test, plasma renin activity or PRA, is being measured during the visits outlined.
Outcome measures
| Measure |
Aliskiren and Metoprolol
n=1 Participants
Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
|
|---|---|
|
Plasma Renin Activity
Screening
|
2.07 ng/mL/h
|
|
Plasma Renin Activity
Week 4
|
1.22 ng/mL/h
|
|
Plasma Renin Activity
Week 6
|
0.28 ng/mL/h
|
|
Plasma Renin Activity
Week 7
|
0.18 ng/mL/h
|
|
Plasma Renin Activity
Week 9
|
0.28 ng/mL/h
|
|
Plasma Renin Activity
Week 10
|
0.07 ng/mL/h
|
|
Plasma Renin Activity
Week 11
|
0.03 ng/mL/h
|
|
Plasma Renin Activity
Week 12
|
0.06 ng/mL/h
|
SECONDARY outcome
Timeframe: all visits (weekly for 12 weeks)Outcome measures
| Measure |
Aliskiren and Metoprolol
n=1 Participants
Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
|
|---|---|
|
Blood Pressure
Week 3-Systolic
|
148 mm Hg
|
|
Blood Pressure
Week 3-Diastolic
|
90 mm Hg
|
|
Blood Pressure
Week 1-Systolic
|
146 mm Hg
|
|
Blood Pressure
Week 1-Diastolic
|
64 mm Hg
|
|
Blood Pressure
Week 2-Systolic
|
144 mm Hg
|
|
Blood Pressure
Week 2-Diastolic
|
88 mm Hg
|
|
Blood Pressure
Week 4-Systolic
|
148 mm Hg
|
|
Blood Pressure
Week 4-Diastolic
|
92 mm Hg
|
|
Blood Pressure
Week 5-Systolic
|
156 mm Hg
|
|
Blood Pressure
Week 5-Diastolic
|
92 mm Hg
|
|
Blood Pressure
Week 6-Systolic
|
150 mm Hg
|
|
Blood Pressure
Week 6-Diastolic
|
84 mm Hg
|
|
Blood Pressure
Week 7-Systolic
|
157 mm Hg
|
|
Blood Pressure
Week 7-Diastolic
|
89 mm Hg
|
|
Blood Pressure
Week 8-Systolic
|
147 mm Hg
|
|
Blood Pressure
Week 8-Diastolic
|
76 mm Hg
|
|
Blood Pressure
Week 9-Systolic
|
129 mm Hg
|
|
Blood Pressure
Week 9 -Diastolic
|
94 mm Hg
|
|
Blood Pressure
Week 10-Systolic
|
139 mm Hg
|
|
Blood Pressure
Week 10-Diastolic
|
79 mm Hg
|
|
Blood Pressure
Week 11-Systolic
|
170 mm Hg
|
|
Blood Pressure
Week 11-Diastolic
|
90 mm Hg
|
|
Blood Pressure
Week 12-Systolic
|
146 mm Hg
|
|
Blood Pressure
Week 12-Diastolic
|
78 mm Hg
|
Adverse Events
Aliskiren and Metoprolol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aliskiren and Metoprolol
n=1 participants at risk
Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
|
|---|---|
|
Immune system disorders
Leukocytosis
|
100.0%
1/1 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place