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

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: Bendrofluazide

Drug: Lacidipine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02235402

231.336

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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