HypertensionPhase 4NCT02235402
A Randomised, Parallel-group, Double-blind, Double-dummy Study to Compare the Effects of Lacidipine Versus Bendrofluazide on Markers of Platelet Activation and Haemorheological Factors in Hypertensive Patients
A Phase 4 study testing Lacidipine and Bendrofluazide in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
The aim of this study is to compare the effects of lacidipine on markers of platelet activation and other rheological factors in hypertensive patients with those of bendrofluazide Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Lacidipine and Bendrofluazide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Dec 1997to Mar 2000
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or over
- Hypertensive at screening: Diastolic blood pressure (DBP) 95 - 115 mm Hg and / or systolic blood pressure (SBP) >= 160 mm Hg on no therapy or on monotherapy. If currently on monotherapy, DBP could have been < 95 mm Hg and SBP < 160 mm Hg, but the patient must have been experiencing unacceptable side effects from their current treatment. Patient must then be able to stop treatment for the placebo run in phase of four weeks without endangering their health (at investigator's discretion)
- Hypertensive at randomisation: DBP 95-115 mm Hg and or SBP >=160
- Able to give written informed consent
Who cannot join
- Grad III or grad IV hypertensive retinopathy
- Renal impairment; serum creatinine > 150 µmol/L
- Heart failure. (New York Heart Association (NYHA) Class III or IV)
- Liver impairment (abnormal Liver function test (LFT) with aspartate-amino transferase (AST) / alanine-amino transferase (ALT) > 2x upper normal limit or bilirubin > 2x upper normal limit)
- Recent (< 2 months) history of unstable angina
- Recent (< 2 months) history of myocardial infarction
Show all 26Show fewer
- Recent (< 2 months) history of stroke
- History of diabetes mellitus or impaired glucose tolerance or random blood glucose >= 9 mMol/L
- Any acute systemic illness or infection
- Any severe disease which could interfere with survival or well-being during the study (e.g. malignancy)
- Patients of child bearing potential
- Current or previous drug and / or alcohol abuse
- Severely limited venous access
- Haemoglobin < 10g/dL (male patients), haemoglobin < 9g/dL (female patients)
- Requirement for anticoagulant therapy
- Severe valvular heart disease (investigator's discretion)
- Atrial fibrillation or other serious cardiac dysrhythmia
- History of thyroid disease or abnormal thyroid function test (thyroid stimulating hormone (TSH) < 0.4 mU/L or > 5.4 mU/L)
- History of connective tissue disorder
- Concurrent participation in any other clinical trial or participation within two months enrolment
- Requirement for restricted drugs
- Patients currently on treatment with lacidipine or bendrofluazide (BNFZ)
- Patients unable to attend clinics
- Any clinical condition which in the opinion of the investigator, would preclude the safe fulfillment of the protocol and the safe administration of trial medication
- Seated blood pressure (BP) exceeding either 210 mm Hg (systolic) or 115 mm Hg (diastolic) at screening or randomization
- Standing BP < 140 mm Hg (systolic) and < 95 mm Hg (diastolic) at randomization
About this study
The aim of this study is to compare the effects of lacidipine on markers of platelet activation and other rheological factors in hypertensive patients with those of bendrofluazide
- Conditions
- Hypertension
- Being tested
- Lacidipine, Bendrofluazide, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacidipineDrug
BendrofluazideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lacidipine | Experimental | Not described Receives: Drug: Lacidipine |
| Bendrofluazide | Active comparator | Not described Receives: Drug: Bendrofluazide |
| 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.
Changes in ß-TG (thromboglobulin)
Measured: Up to week 12 after drug administration
Secondary outcomes (5)
Changes in soluble p-selectin
Measured: Up to week 12 after drug administration
Changes in rheological factors
Measured: Up to week 12 after drug administration
Changes in lipid levels between randomisation and last visit
Measured: Up to week 12 after drug administration
Number of patients with clinical significant findings in laboratory parameters
Measured: Up to week 12 after drug administration
Number of patients with adverse events
Measured: Up to week 12 after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startDec 1997
- Primary completionMar 2000
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 Boehringer IngelheimThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235402
- Sponsor's protocol ID
- 231.336
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 10 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel-group, Double-blind, Double-dummy Study to Compare the Effects of Lacidipine Versus Bendrofluazide on Markers of Platelet Activation and Haemorheological Factors in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02235402
- Acronym / sponsor ID
- 231.336
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 1997
- Primary completion
- Mar 2000 (actual)
- First posted
- 10 Sep 2014 (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 aim of this study is to compare the effects of lacidipine on markers of platelet activation and other rheological factors in hypertensive patients with those of bendrofluazide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lacidipine | Experimental | Drug: Lacidipine |
| Bendrofluazide | Active comparator | Drug: Bendrofluazide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or over
- Hypertensive at screening: Diastolic blood pressure (DBP) 95 - 115 mm Hg and / or systolic blood pressure (SBP) >= 160 mm Hg on no therapy or on monotherapy. If currently on monotherapy, DBP could have been < 95 mm Hg and SBP < 160 mm Hg, but the patient must have been experiencing unacceptable side effects from their current treatment. Patient must then be able to stop treatment for the placebo run in phase of four weeks without endangering their health (at investigator's discretion)
- Hypertensive at randomisation: DBP 95-115 mm Hg and or SBP >=160
- Able to give written informed consent
Key exclusion criteria (26 listed)
- Grad III or grad IV hypertensive retinopathy
- Renal impairment; serum creatinine > 150 µmol/L
- Heart failure. (New York Heart Association (NYHA) Class III or IV)
- Liver impairment (abnormal Liver function test (LFT) with aspartate-amino transferase (AST) / alanine-amino transferase (ALT) > 2x upper normal limit or bilirubin > 2x upper normal limit)
- Recent (< 2 months) history of unstable angina
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 |
|---|---|---|
| Lacidipine | Drug | Lacidipine |
| Bendrofluazide | Drug | Bendrofluazide |
| Placebo | Drug | Placebo |
Primary outcome
Changes in ß-TG (thromboglobulin)
Time frame: Up to week 12 after drug administration
5 secondary outcomes
Changes in soluble p-selectin
Time frame: Up to week 12 after drug administration
Changes in rheological factors
Time frame: Up to week 12 after drug administration
Changes in lipid levels between randomisation and last visit
Time frame: Up to week 12 after drug administration
Number of patients with clinical significant findings in laboratory parameters
Time frame: Up to week 12 after drug administration
Number of patients with adverse events
Time frame: Up to week 12 after drug administration
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 10 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lacidipine and Bendrofluazide in people with Hypertension, run by Boehringer Ingelheim.
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 4 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 10 Sep 2014. 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. 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?
Changes in ß-TG (thromboglobulin) (time frame: Up to week 12 after drug administration). 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 10 Sep 2014.