Telmisartan Plus Hydrochlorothiazide in Subjects With Mild-to-moderate Hypertension Who Failed to Respond to Telmisartan Monotherapy

NCT ID: NCT02177500

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31

Brief Summary

An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic blood pressure in patients who fail to respond adequately to telmisartan monotherapy.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Telmisartan + hydrochlorothiazide and matching placebo

Group Type: EXPERIMENTAL

Telmisartan + hydrochlorothiazide

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Telmisartan and matching placebo

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Telmisartan + hydrochlorothiazide

Intervention Type: DRUG

Telmisartan

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• History of mild-to-moderate hypertension
• Patients who fail to respond adequately to telmisartan monotherapy
• Participants between 18 and 80 years of age
• Willingness and ability to provide written informed consent

Exclusion Criteria

• Patients taking more than three anti-hypertensive medications at the screening visit
• Pre-menopausal women

• Who are not surgically sterile
• Who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device (IUD), oral, implantable or injectable contraceptives
• Any women:

• Who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 3)
• Who is nursing
• Hepatic and/or renal dysfunction as defined by the following laboratory parameters

• SGPT (serum glutamate pyruvate transaminase) or SGOT (serum glutamate oxaloacetate transaminase) greater than two times the upper limit of normal
• Serum creatinine > 2.3 mg/dL
• Clinically relevant sodium depletion, hyperkalemia, or hypokalemia at baseline
• Known or suspected secondary hypertension
• Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
• Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)
• Unstable angina within the past three months
• Stroke within the past six months
• Myocardial infarction or cardiac surgery within the past three months
• PTCA (percutaneous transluminal coronary angioplasty) within the past three months
• History of symptoms characteristic of angioedema during treatment with ACE inhibitors, angiotension II antagonists, thiazide diuretics, β-blockers or calcium channel blockers
• Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
• Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
• Administration of digoxin or other digitalis-type drugs
• Patients with Type I or Type II diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥ 10%
• Known drug or alcohol dependency within the past one year period
• Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
• Patients receiving any investigational therapy within one month of signing the informed consent form. Patients who have participated in previous telmisartan (except if they were on the fixed dose combination in the 502.261 study or enrolled in the 502.321 open-label extension study) studies may participate in this study provided there has been at least one month between discontinuing the previous study and signing the consent for the present study
• Known hypersensitivity to any component of the formulations
• Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of trial medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

502.323

Identifier Type: -

Identifier Source: org_study_id