HypertensionPhase 4hassNCT01388088
The Effect of Amiloride and Spironolactone in Patients With Hypertension
A Phase 4 study testing Spironolactone and Amiloride in people with Hypertension, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
Trial summary
The investigators wish to investigate the potential effects of potassium. In this study we will examine patients with hypertension and increase their potassium-levels using Amiloride and Spironolactone. The investigators will examine the changes in the cardiovascular system using a Sphygmocor-scanner. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Spironolactone and Amiloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Feb 2012
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension
- Age 45-70
- BMI: 18,5-30
Who cannot join
- Other diseases
- Drug or alcohol abuse
- Abnormal findings in the screening procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables in Patients With Essential Hypertension in a Doublle-blinded Randomised Placebo-controlled, Cross-over Study.
The investigators wish to investigate the potential effects of potassium. In this study we will examine patients with hypertension and increase their potassium-levels using Amiloride and Spironolactone.
The investigators will examine the changes in the cardiovascular system using a Sphygmocor-scanner.
Read the detailed description
Purpose of the study is to examine the effect of amilorid and spironolacton on
- Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
- Pulsewavevelocity, augmentation index and centralt bloodpressure,
- Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
- Ambulatory blood pressure
- Conditions
- Hypertension
- Being tested
- Spironolactone, Amiloride, Placebo
- Keywords
- Hypertension, Potassium, Blood-pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
25 mg twice a day
AmilorideDrug
5 mg twice a day
PlaceboDrug
twice a day
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone | Active comparator | Increases the level of potassium Receives: Drug: Spironolactone |
| Amiloride | Active comparator | Increases the level of potassium Receives: Drug: Amiloride |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
24 hours blood pressure measurements
Measured: 2 years
Secondary outcomes (1)
Pulse wave velocity
We will investigate the changes in cardiovascular variables using a Sphygmocor scanner.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erling Bjerregaard Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Solveig K Matthesen, Cand.Med, Principal investigator, Medical Research Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388088
- Sponsor's protocol ID
- MED.RES.HOS.2010.02.SKM
- Acronym
- hass
- Status last verified
- Mar 2012
- First submitted
- 19 May 2010
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables in Patients With Essential Hypertension in a Doublle-blinded Randomised Placebo-controlled, Cross-over Study.
- ClinicalTrials.gov ID
- NCT01388088
- Acronym / sponsor ID
- hass / MED.RES.HOS.2010.02.SKM
- Conditions
- Hypertension
- Keywords
- Hypertension, Potassium, Blood-pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Jul 2011 (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.
The investigators wish to investigate the potential effects of potassium. In this study we will examine patients with hypertension and increase their potassium-levels using Amiloride and Spironolactone.
The investigators will examine the changes in the cardiovascular system using a Sphygmocor-scanner.
Detailed description
Purpose of the study is to examine the effect of amilorid and spironolacton on
- Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
- Pulsewavevelocity, augmentation index and centralt bloodpressure,
- Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
- Ambulatory blood pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | Active comparator | Drug: SpironolactoneIncreases the level of potassium |
| Amiloride | Active comparator | Drug: AmilorideIncreases the level of potassium |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertension
- Age 45-70
- BMI: 18,5-30
Key exclusion criteria (3 listed)
- Other diseases
- Drug or alcohol abuse
- Abnormal findings in the screening procedure
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 |
|---|---|---|
| Spironolactone25 mg twice a day | Drug | Spironolactone |
| Amiloride5 mg twice a day | Drug | Amiloride |
| Placebotwice a day | Drug | Placebo |
Primary outcome
Blood pressure
Time frame: 2 years
24 hours blood pressure measurements
1 secondary outcome
Pulse wave velocity
Time frame: 2 years
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 28 Mar 2012.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Solveig K Matthesen, Cand.Med principal investigator
Medical Research Department
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 Spironolactone and Amiloride in people with Hypertension, run by Erling Bjerregaard Pedersen 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 3 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 28 Mar 2012. 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. Some participants in this study may receive a placebo. 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?
Blood pressure (time frame: 2 years). 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 28 Mar 2012.