Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan) or Hydrochlorothiazide in the Management of Patients With Isolated Systolic Hypertension (ISH)

NCT02175355 | Completed Phase 3

• 1 other identifier: 502.254
• Study Type: interventional
• Target: 1,039
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary: To identify doses of Micardis®(telmisartan) which, administered once daily, are more effective than placebo and not inferior to HCTZ in lowering systolic blood pressure (SBP) in patients with isolated systolic hypertension (ISH), and to assess the dose response relationship of the antihypertensive effect of telmisartan over the dose range of 20 to 80 mg. Secondary: Target fall in SBP, change from baseline in seated DBP. Safety and tolerability of Micardis® and HCTZ in patients with ISH as measured by changes in physical examinations, heart rate, laboratory parameters and/or 12-lead ECG, as well as the incidence and severity of adverse events.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• Change from baseline in seated systolic blood pressure at trough (24 hours post-dose)

  after 6 weeks of treatment

• Change from baseline in urine albumine excretion rate

  after 6 weeks of treatment

• Change from baseline in pulse wave velocity

  after 6 weeks of treatment

Secondary Outcomes (8)

• Percentage of patients achieving a target fall in SBP

  after 6 weeks of treatment

• Changes in seated diastolic blood pressure (DBP)

  up to 6 weeks

• Change from baseline in augmentation index

  after 6 weeks of treatment

• Incidence and intensity of adverse events

  up to 6 weeks

• Number of patients with relevant changes from baseline in physical examination

  baseline, week 6

Study Arms (5)

Low dose of Micardis®

EXPERIMENTAL

Drug: Low dose of Micardis®

Medium dose of Micardis®

EXPERIMENTAL

Drug: Medium dose of Micardis®

High dose of Micardis®

EXPERIMENTAL

Drug: High dose of Micardis®

Hydrochlorothiazide

ACTIVE COMPARATOR

Drug: Hydrochlorothiazide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Low dose of Micardis® DRUG

Low dose of Micardis®

Medium dose of Micardis® DRUG

Medium dose of Micardis®

High dose of Micardis® DRUG

High dose of Micardis®

Hydrochlorothiazide DRUG

Hydrochlorothiazide

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 35 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 35 years, but less than 85 years of age
• Mean SBP ≥ 150 mm Hg and mean DBP \< 90 mm Hg at the randomisation visit (visit 2), according to WHO definitions of ISH (excluding the subgroup of borderline ISH)
• Hypertensive patients not on current antihypertensive therapy or able to stop current treatment for a period of up to 8 - 10 weeks without endangering the health of the patient (investigator's discretion)
• Ability to provide written informed consent

You may not qualify if:

• Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:
• are not surgically sterile; and/or
• are nursing
• are of child-bearing potential and are not practicing acceptable means of birth control or do NOT plan to continue using this method throughout the study. Acceptable methods of birth control include oral, implantable or injectable contraceptives
• Mean systolic blood pressure ≥ 180 mmHg at the randomization Visit 2
• Known or suspected secondary hypertension
• Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
• Serum glutamic pyruvate transaminase (ALT) or serum glutamic oxaloacetic transaminase (AST) \> than 2 times the upper limit of normal range
• Serum creatinine \> or 1.8 mg/dl (or 159 µmol/l)
• Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney
• Clinically relevant hypokalemia or hyperkalemia
• Uncorrected volume or sodium depletion
• Primary aldosteronism
• Hereditary fructose intolerance
• Biliary obstructive disorders

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; 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; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 26, 2014
• Study Start: October 1, 1999
• Primary Completion: August 1, 2000
• Last Updated: July 8, 2014

Record last verified: 2014-07