HypertensionPhase 4NCT00334386

Hypertension Study: Multinational Torasemide Trial in Mild to Moderate Hypertension.

A Phase 4 study testing Torasemide Prolonged Release (loop diuretic) and Torasemide Immediate Release (loop diuretic) in people with Hypertension, run by Ferrer Internacional S.A..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary objective:To demonstrate the no-inferiority in efficacy of treatment with Torsemide-PR in relation to Torsemide-IR in patients with mild and/or moderate hypertension. Secondary objectives: To evaluate the safety and tolerability of Torsemide-PR. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypertension
What is being tested?: Torasemide Prolonged Release (loop diuretic) and Torasemide Immediate Release (loop diuretic)
How many people: 388 participants
Where: No sites listed yet
Study dates: Apr 2005to Feb 2006
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged from 18 to 75, inclusive.
Ambulatory patients diagnosed with mild or moderate arterial hypertension complying with the following requirements:
Patients diagnosed "de novo".
Patients with prior anti-hypertensive treatment in monotherapy who do not respond to the treatment and, in the investigator's opinion, could benefit from diuretic treatment in monotherapy.
Patients with prior anti-hypertensive treatment in monotherapy who do not tolerate the current treatment and, in the investigator's opinion, could benefit from diuretic treatment in monotherapy.
Patients with prior treatment must be able to interrupt their present treatment for a period of up to 3 months.

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(Mild or moderate hypertension defined by blood pressure levels: Systolic blood pressure from 140-179 mm Hg and diastolic blood pressure from 90-109 mm Hg) (2003 European Society of Hypertension-European Society of Cardiology guidelines for management of arterial hypertension) (3)
Capable of understanding the nature of the trial.
Providing their informed consent in writing.

Who cannot join

Pregnant or breastfeeding women and women of fertile age who are not using a safe contraceptive method or do not intend to use one during the trial. Safe contraceptive methods are oral or parenteral contraceptive treatments or barrier methods: masculine or feminine condom, diaphragm and/or IUD.
Severe arterial hypertension (systolic blood pressure of 180 mmHg or above and diastolic blood pressure of 110 mmHg or above).
Known or suspected secondary arterial hypertension.
History of known hypersensitivity to the compound under study or to sulfonylureas.
History of repeated and documented hypertensive crises.
NYHA grade II to IV congestive heart failure.

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Severe cardiac arrhythmia (sustained ventricular tachycardia, auricular fibrillation, auricular flutter, bradycardia under 45 beats per minute).
Unstable angina pectoris.
Acute myocardial infarct in the last 6 months.
Liver failure defined by the following analytical parameters: - SGPT (ALT) or SGOT (AST) over twice the upper normal limit.
Chronic kidney failure defined by the following analytical parameters: Serum creatinine over 2.3 mg/dl (or 203 mol/L).
Patients with insulin-dependent diabetes and patients with non-insulin dependent diabetes.
Cerebrovascular accident in the last 6 months.
Contraindications in the data obtained during the selection process in the physical examination, haematology, biochemistry, urine analysis and 12-lead ECG, in the investigator's opinion.
Simultaneous participation in another clinical trial or treatment with any investigational drug within the 30 days prior to signing the informed consent form.
Lactose intolerance.
Concomitant treatment with lithium.
Patients requiring chronic treatment (treatment > 7 days) with non-steroidal anti-inflammatory drugs, including aspirin.
Patients with concomitant treatment with aminoglycoside antibiotics, etacrynic acid.
Chronic administration of any medication affecting blood pressure.
Patients in treatment with group 1a, 1b or 2 anti-arrhythmic drugs.
History of drug or alcohol addiction within the 6 months prior to the start of the trial.
Any clinical circumstance or condition which, in the investigator's opinion, could affect the possibility of completing the protocol and the administration of Torasemide.
Obesity with a body mass index (BMI) of over 40 kg/m2.
Patients who do not respond to diuretic treatment in monotherapy.
Patients with prior anti-hypertensive treatment in monotherapy who are candidates for anti-hypertensive treatment in polytherapy.

About this study

Official title: Multicentre, Multinational, Parallel, Randomised, Double Blind Clinical Trial, to Evaluate the Non-inferiority of PR Torasemide Versus IR Torasemide in Patients With Mild or Moderate Arterial Hypertension.

Primary objective:To demonstrate the no-inferiority in efficacy of treatment with Torsemide-PR in relation to Torsemide-IR in patients with mild and/or moderate hypertension.

Secondary objectives: To evaluate the safety and tolerability of Torsemide-PR.

Read the detailed description

Torsemide is a loop diuretic from the group of pyridine-sulfonylureas, which acts on the ascending large portion of the Henle loop where it inhibits the Na+/K+/2Cl- transport!system and blocks Cl- channels.Therefore, sodium and chlorine ions and water can not be reabsorbed in the tubule and the urine volume increases significantly. Torsemide is used for the treatment of oedema associated with congestive heart failure, kidney or liver disease and, either alone or combined with other anti-hypertensive drugs, for the treatment of arterial hypertension.

This trial compares the effect of a new formulation of Torasemide (Torasemide prolonged release)to the already available immediate release formulation of the same drug on the treatment of mild to moderate hypertensive patients.

Eligible patients will be randomised to either treatment with Torasemide prolonged release or with Torasemide immediate release and will be followed-up until completing 3 months of treatment.Blood pressure will be measured by an OMRON pressure gauge. Additionally, ABPM will be performed on a sub-group of the patients taking part in this trial.

Conditions: Hypertension
Being tested: Torasemide Prolonged Release (loop diuretic), Torasemide Immediate Release (loop diuretic)
Keywords: Hypertension, Anti-hypertensive effect, Diuretic
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Torasemide Prolonged Release (loop diuretic)Drug
Torasemide Immediate Release (loop diuretic)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in mm Hg between the mean diastolic blood pressure (DBP) values the baseline period and the values at the end of the treatment period.

Secondary outcomes (5)

Difference in mm Hg, systolic blood pressure (SBP) values in the baseline period and the values at the end of the treatment period.
Percentage of patients with controlled blood pressure (SBP < 140 and/or DBP < 90) at the end of the treatment period.
Urinary symptoms.
ABPM values measured in a subgroup of patients
Safety & tolerability.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2005Feb 2006

First posted7 Jun 2006 (estimated)
Study startApr 2005
Study completionFeb 2006

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: Parallel groups
Masking: Double blind
Enrolment: 388 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00334386
Sponsor's protocol ID: P030089-01
Other IDs: EudraCT: 2004-000876-14
Status last verified: Mar 2015
First submitted: 6 Jun 2006
Last updated: 6 Mar 2015
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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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
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentre, Multinational, Parallel, Randomised, Double Blind Clinical Trial, to Evaluate the Non-inferiority of PR Torasemide Versus IR Torasemide in Patients With Mild or Moderate Arterial Hypertension.
ClinicalTrials.gov ID: NCT00334386
Acronym / sponsor ID: P030089-01
Conditions: Hypertension
Keywords: Hypertension, Anti-hypertensive effect, Diuretic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 388 participants
Lead sponsor: Ferrer Internacional S.A.Industry (pharma, biotech, devices)
Study start: Apr 2005
Study completion: Feb 2006
First posted: 7 Jun 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.

Primary objective:To demonstrate the no-inferiority in efficacy of treatment with Torsemide-PR in relation to Torsemide-IR in patients with mild and/or moderate hypertension.

Secondary objectives: To evaluate the safety and tolerability of Torsemide-PR.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Aged from 18 to 75, inclusive.
Ambulatory patients diagnosed with mild or moderate arterial hypertension complying with the following requirements:
Patients with prior treatment must be able to interrupt their present treatment for a period of up to 3 months.
(Mild or moderate hypertension defined by blood pressure levels: Systolic blood pressure from 140-179 mm Hg and diastolic blood pressure from 90-109 mm Hg) (2003 European Society of Hypertension-European Society of Cardiology guidelines for management of arterial hypertension) (3)
Capable of understanding the nature of the trial.

Key exclusion criteria (26 listed)

Pregnant or breastfeeding women and women of fertile age who are not using a safe contraceptive method or do not intend to use one during the trial. Safe contraceptive methods are oral or parenteral contraceptive treatments or barrier methods: masculine or feminine condom, diaphragm and/or IUD.
Severe arterial hypertension (systolic blood pressure of 180 mmHg or above and diastolic blood pressure of 110 mmHg or above).
Known or suspected secondary arterial hypertension.
History of known hypersensitivity to the compound under study or to sulfonylureas.
History of repeated and documented hypertensive crises.

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
Torasemide Prolonged Release (loop diuretic)	Drug	–
Torasemide Immediate Release (loop diuretic)	Drug	–

Primary outcome

Difference in mm Hg between the mean diastolic blood pressure (DBP) values the baseline period and the values at the end of the treatment period.

5 secondary outcomes

Difference in mm Hg, systolic blood pressure (SBP) values in the baseline period and the values at the end of the treatment period.
Percentage of patients with controlled blood pressure (SBP < 140 and/or DBP < 90) at the end of the treatment period.
Urinary symptoms.
ABPM values measured in a subgroup of patients
Safety & tolerability.

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 6 Mar 2015.

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.

Alex Roca, MD, PhD study chair

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Antonio Coca, MD, PhD principal investigator

H. Clínic Barcelona, Barcelona, Spain

Joaquim Vila, MD principal investigator

Hospital Municipal de Badalona, Badalona, Barcelona, Spain

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Torasemide Prolonged Release (loop diuretic) and Torasemide Immediate Release (loop diuretic) in people with Hypertension, run by Ferrer Internacional S.A..

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 9 inclusion and 26 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Difference in mm Hg between the mean diastolic blood pressure (DBP) values the baseline period and the values at the end of the treatment period.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334386.

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 6 Mar 2015.