Telmisartan With or Without Hydrochlorothiazide (HCTZ) Compared With Losartan With or Without HCTZ in Mild to Moderate Hypertensive Patients

NCT02172586 | Completed Phase 4

• 1 other identifier: 502.316
• Study Type: interventional
• Target: 363
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement). Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study, evaluated by sphygmomanometric blood pressure measurement and ABPM Safety: Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment

  Baseline and week 12

Secondary Outcomes (12)

• Change from baseline in DBP during the last 6 hours (ABPM) of the 24-hour dosing interval at the end of the study

  Baseline and week 24

• Change from baseline in systolic blood pressure (SBP) during the last 6 hours (ABPM) of the 24-hour dosing interval

  Baseline, week 12 and 24

• Change from baseline in DBP/SBP during the last 2 hours (ABPM) of the 24-hour dosing interval (trough BP)

  Baseline, week 12 and 24

• Changes from baseline in trough cuff (sphygmomanometer) SBP/DBP

  Baseline, week 12 and 24

• Changes from baseline in SBP/DBP of 24 hours mean ABPM

  Baseline, week 12 and 24

Study Arms (4)

Telmisartan

EXPERIMENTAL

Drug: Telmisartan

Telmisartan + Hydrochlorothiazide

EXPERIMENTAL

Drug: Telmisartan; Drug: Hydrochlorothiazide

Losartan

ACTIVE COMPARATOR

Drug: Losartan

Losartan + Hydrochlorothiazide

ACTIVE COMPARATOR

Drug: Losartan; Drug: Hydrochlorothiazide

Interventions

Telmisartan DRUG

Telmisartan; Telmisartan + Hydrochlorothiazide

Losartan DRUG

Losartan; Losartan + Hydrochlorothiazide

Hydrochlorothiazide DRUG

Losartan + Hydrochlorothiazide; Telmisartan + Hydrochlorothiazide

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Mild-to-moderate essential hypertension defined as a mean diastolic blood pressure (DBP) ≥ 95 mmHg and \< 110 mmHg and systolic blood pressure (SBP) \< 180 mmHg measured by manual cuff sphygmomanometer at the end of the wash-out period
• Written informed consent

You may not qualify if:

• Nursing, pregnancy or childbearing potential women, post-menopausal women will be enrolled with last menstruation \> 1 year prior to start wash-out phase or surgically sterile
• Secondary hypertension
• Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
• Clinically significant sodium depletion as defined by serum sodium level \< 130 mEq/L and/or clinically significant hyperkaliemia as defined by serum potassium level \> 5.5 mEq/L or clinically significant hypokaliemia as defined by serum potassium level \< 3.0 mEq/L
• Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which, in the investigator opinion could compromise patient's participation to the trial
• Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)
• Angina pectoris or myocardial infarction
• Cardiac surgery within the past 3 months prior to start the wash-out period
• Stroke within the past 6 months prior to start the wash-out period
• Renal insufficiency defined as creatininaemia \> 2mg/dl
• Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant, presence of only one functioning kidney
• Liver insufficiency, defined as bilirubinaemia \> 2mg/dl and AST (aspartate aminotransferase) or ALT (alanine-aminotransferase) \> twice the upper normal range
• Clinically significant metabolic and endocrine disease
• Autoimmune disease
• Previous history of angioedema

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Losartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: January 1, 2000
• Primary Completion: January 1, 2002
• Last Updated: June 24, 2014

Record last verified: 2014-06