Clinical trial NCT02235402: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Changes in ß-TG (thromboglobulin)
timeFrame: Up to week 12 after drug administration
Secondary outcomes:
measure: Changes in soluble p-selectin
timeFrame: Up to week 12 after drug administration
measure: Changes in rheological factors
timeFrame: Up to week 12 after drug administration
measure: Changes in lipid levels between randomisation and last visit
timeFrame: Up to week 12 after drug administration
measure: Number of patients with clinical significant findings in laboratory parameters
timeFrame: Up to week 12 after drug administration
measure: Number of patients with adverse events
timeFrame: Up to week 12 after drug administration
Other outcomes:
Locations:
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