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Comparison of Nebivolol and Metoprolol With Exercise and Angiotensin II in Hypertensive Patients
Plain-language guide to NCT01502787: phase 4 randomized trial of Angiotensin II, 46 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01502787
- Phase
- phase 4
- Status
- completed
- Start
- 2009-04
- Completion (planned or actual)
- 2013-06
- Participants
- 46 (actual)
- Design
- randomized, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Hypertension
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Angiotensin II.
It had two arms (groups): Initial treatment with metoprolol (active comparator) and Initial treatment with nebivolol (active comparator).
The registry classes the interventions as drug and procedure.
More on the Plan
There will be a 2-week washout period between the two treatment periods.
SNA, total forearm blood flow, skeletal muscle blood flow, muscle oxygenation, cardiac output, and blood pressure responses to Nebivolol will be compared to responses during Metoprolol in the same subjects.
Who Took Part
Enrollment: 46 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Stage I hypertension (140-159/90-99 mmHg). Men and women age 18-65.
The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: congestive heart failure or coronary artery disease; blood pressure averaging \>159/99 mmhg or resting heart rate \< 55 bpm; asthma or chronic obstructive pulmonary diseases.
How the Study Was Run
It was run as a randomized, crossover and open-label study.
Random assignment meant chance, not the researchers, decided who got Angiotensin II and who got the comparison, which limits bias.
Each person switched between Angiotensin II and the comparison at some point, usually with a gap in between.
Being open-label, the Angiotensin II study did not mask who received what.
It started in 2009-04 with completion listed for 2013-06.
It ran at 1 site in United States.
Its stated primary purpose is diagnostic.
What Was Measured
The main thing measured (primary outcome): Forearm Blood Flow (time frame: 12 weeks after each specified medication).
It also tracked 2 secondary outcomes, for example Blood Pressure During Exercise and Blood Pressure During Angiotensin II Infusion.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Angiotensin II in 46 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Angiotensin II compound page, all human trials.
Our Notes on the Compound
Angiotensin II: An 8-amino-acid hormone that narrows blood vessels; synthetic angiotensin II (Giapreza) is used for low blood pressure in shock.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.