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

NCT02235402 | Completed Phase 4

• 1 other identifier: 231.336
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in ß-TG (thromboglobulin)

  Up to week 12 after drug administration

Secondary Outcomes (5)

• 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

Study Arms (3)

Lacidipine

EXPERIMENTAL

Drug: Lacidipine

Bendrofluazide

ACTIVE COMPARATOR

Drug: Bendrofluazide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lacidipine DRUG

Lacidipine

Bendrofluazide DRUG

Bendrofluazide

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

lacidipine; Bendroflumethiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 10, 2014
• Study Start: December 1, 1997
• Primary Completion: March 1, 2000
• Last Updated: September 10, 2014

Record last verified: 2014-09