HealthyPhase 4NCT00311974
The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals
A Phase 4 study testing Dihydralazine in people with Healthy, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine leads to the activation of the sympathetic nervous system in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dihydralazine
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2006to Nov 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men
- Ages 18 to 40 years.
- Body mass index less than or equal to 30 kg/m2
Who cannot join
- History or clinical signs of heart, lung, kidney, or endocrine organ disease.
- Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.
- Abnormal screening of the urine regarding: albumin and glucose
- Malignant disease.
- Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.
- Alcohol abuse.
Show all 10Show fewer
- Smoking.
- Drug use or abuse.
- Known intolerance or allergy to dihydralazine
- Blood donation within 1 month of the start of the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medical Research, Holstebro Hospital
Holstebro, 7500
About this study
Official title: The Effect of Dihydralazine on Renal Tubular Function and Vasoactive Hormones in Healthy Individuals
We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine leads to the activation of the sympathetic nervous system in healthy individuals.
- Conditions
- Healthy
- Being tested
- Dihydralazine
- Keywords
- Dihydralazine, Sympathetic activation, Fractional sodium excretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DihydralazineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional sodium excretion
Heart rate
Blood pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 16 participants
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Erling B Pedersen, Professor, Study chair, Department of Medical Research, Holstebro Hospital, DenmarkHenrik Vase, MD, Principal investigator, Department of Medical Research, Holstebro Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311974
- Sponsor's protocol ID
- MED.RES.HOS.2006.01.HV
- Other IDs
- 99127500
- Status last verified
- Feb 2010
- First submitted
- 5 Apr 2006
- Last updated
- 18 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dihydralazine on Renal Tubular Function and Vasoactive Hormones in Healthy Individuals
- ClinicalTrials.gov ID
- NCT00311974
- Acronym / sponsor ID
- MED.RES.HOS.2006.01.HV
- Conditions
- Healthy
- Keywords
- Dihydralazine, Sympathetic activation, Fractional sodium excretion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 7 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine leads to the activation of the sympathetic nervous system in healthy individuals.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men
- Ages 18 to 40 years.
- Body mass index less than or equal to 30 kg/m2
Key exclusion criteria (10 listed)
- History or clinical signs of heart, lung, kidney, or endocrine organ disease.
- Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.
- Abnormal screening of the urine regarding: albumin and glucose
- Malignant disease.
- Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dihydralazine | Drug | – |
Primary outcome
Fractional sodium excretion
Heart rate
Blood pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erling B Pedersen, Professor study chair
Department of Medical Research, Holstebro Hospital, Denmark
Henrik Vase, MD principal investigator
Department of Medical Research, Holstebro Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dihydralazine in people with Healthy, run by Regional Hospital Holstebro at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional sodium excretion. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2010.