HypertensionPhase 3UranicNCT02558023
The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine
A Phase 3 study testing Urapidil and Nicardipine in people with Hypertension and Preeclampsia, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
The objective of this study is to demonstrate that urapidil is not inferior to nicardipine for the treatment of hypertension associated with preeclampsia (PE) and that it is better tolerated. efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min of study drug administration. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension, Preeclampsia
- What is being tested?
- Urapidil and Nicardipine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2015to Aug 2020
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Singleton pregnancy
- Patients with remaining hypertension despite an oral treatment for who an iv antihypertensive treatment is indicated
- Patient with PE, as defined by :
- Systolic Blood Pressure (BP) ≥ 140 mmHg and/or Diastolic BP ≥ 90 mmHg, after the 20th week of amenorrhea, without chronic hypertension, AND
- Proteinuria > 300 mg.day-1 or > 2 crosses(++) on an urinary dipstick,
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- OR
- Patient with severe Pregnancy Induced Hypertension (PIH), as defined by :
- Systolic BP ≥ 160 mmHg and/or Diastolic BP ≥110 mmHg, after the 20th week of amenorrhea, without chronic hypertension,
- Written informed consent signed and dated by both investigator and patient,
- Valid social security affiliation
Who cannot join
- Known allergy to study drugs
- Contra-indication to the study drugs: stenosis of the aortic isthmus, arteriovenous shunt, coarctation of the aorta, unstable angina, compensatory hypertension, myocardial infarction < 8 days.
- Eclampsia
- Person with difficulty understanding information
- Person with diminished responsibility,
- Ongoing intravenous antihypertensive treatment,
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- No pressure cuff adapted to the morphology of the arms of the patients
- Concomitant use of 5 phosphodiesterase inhibitors
- Participation in a clinical trial within 6 months prior to inclusion
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service d'Anesthésie - CMCO
Schiltigheim, 67303
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
About this study
Official title: The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial
The objective of this study is to demonstrate that urapidil is not inferior to nicardipine for the treatment of hypertension associated with preeclampsia (PE) and that it is better tolerated.
- efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min of study drug administration.
- safety endpoints : clinical and biological observation for any side effect. All infants will be observed in the neonatology unit (during 48h).
Pharmacokinetic study included to study :
- transplacental transfer,
- transfer in breast milk,
- and neonatal elimination (premature babies of mothers treated with urapidil (less than 33 WG))
- Conditions
- Hypertension, Preeclampsia
- Being tested
- Urapidil, Nicardipine
- Keywords
- PRE-ECLAMPSIA, URAPIDIL, NICARDIPINE
- Medical subject headings
- Hypertension, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrapidilDrug
Urapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg.
The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes.
Maximum dose of 30 mg.h-1.
NicardipineDrug
Nicardipine : IV
1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes.
Maximum dose of 6 mg.h-1
| Study group | Role | What they receive |
|---|---|---|
| Urapidil | Experimental | Urapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg.
The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes.
Maximum dose of 30 mg.h-1. Receives: Drug: Urapidil |
| Nicardipine | Active comparator | Nicardipine : IV
1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes.
Maximum dose of 6 mg.h-1 Receives: Drug: Nicardipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure at two hours
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2020
- Study completionAug 2020
Why it stopped: no candidats
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.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre DIEMUNSCH, PUPH, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558023
- Sponsor's protocol ID
- 5866
- Acronym
- Uranic
- Status last verified
- Aug 2019
- First submitted
- 24 Aug 2015
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial
- ClinicalTrials.gov ID
- NCT02558023
- Acronym / sponsor ID
- Uranic / 5866
- Conditions
- Hypertension, Preeclampsia
- Keywords
- PRE-ECLAMPSIA, URAPIDIL, NICARDIPINE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no candidats
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 23 Sep 2015 (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 objective of this study is to demonstrate that urapidil is not inferior to nicardipine for the treatment of hypertension associated with preeclampsia (PE) and that it is better tolerated.
- efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min of study drug administration.
- safety endpoints : clinical and biological observation for any side effect. All infants will be observed in the neonatology unit (during 48h).
Pharmacokinetic study included to study :
- transplacental transfer,
- transfer in breast milk,
- and neonatal elimination (premature babies of mothers treated with urapidil (less than 33 WG))
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urapidil | Experimental | Drug: UrapidilUrapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg. The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes. Maximum dose of 30 mg.h-1. |
| Nicardipine | Active comparator | Drug: NicardipineNicardipine : IV 1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes. Maximum dose of 6 mg.h-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult patients
- Singleton pregnancy
- Patients with remaining hypertension despite an oral treatment for who an iv antihypertensive treatment is indicated
- Systolic Blood Pressure (BP) ≥ 140 mmHg and/or Diastolic BP ≥ 90 mmHg, after the 20th week of amenorrhea, without chronic hypertension, AND
- Proteinuria > 300 mg.day-1 or > 2 crosses(++) on an urinary dipstick,
Key exclusion criteria (9 listed)
- Known allergy to study drugs
- Contra-indication to the study drugs: stenosis of the aortic isthmus, arteriovenous shunt, coarctation of the aorta, unstable angina, compensatory hypertension, myocardial infarction < 8 days.
- Eclampsia
- Person with difficulty understanding information
- Person with diminished responsibility,
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 |
|---|---|---|
| UrapidilUrapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg. The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes. Maximum dose of 30 mg.h-1. | Drug | Urapidil |
| NicardipineNicardipine : IV 1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes. Maximum dose of 6 mg.h-1 | Drug | Nicardipine |
Primary outcome
Blood pressure at two hours
Time frame: up to 4 days
Results and safety
The study was stopped early (reason given: no candidats). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
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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.
Pierre DIEMUNSCH, PUPH principal investigator
Hôpitaux Universitaires de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Urapidil and Nicardipine in people with Hypertension and Preeclampsia, run by University Hospital, Strasbourg, France at 2 sites in France.
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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: no candidats). Results are not available in the source record.
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 at two hours (time frame: up to 4 days). 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 25 Aug 2020.