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

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: Lacidipine; Drug: Bendrofluazide

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Lacidipine	Drug: Lacidipine
Active Comparator: Bendrofluazide	Drug: Bendrofluazide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in ß-TG (thromboglobulin)	Up to week 12 after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in soluble p-selectin	Up to week 12 after drug administration
Changes in rheological factors	Up to week 12 after drug administration
Changes in lipid levels between randomisation and last visit	Up to week 12 after drug administration
Number of patients with clinical significant findings in laboratory parameters	Up to week 12 after drug administration
Number of patients with adverse events	Up to week 12 after drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 1997
• Primary Completion (Actual): March 1, 2000

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Estimate): September 10, 2014
• Last Update Submitted That Met QC Criteria: September 9, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Sodium Chloride Symporter Inhibitors; Bendroflumethiazide; Lacidipine
• Other Study ID Numbers: 231.336