Telmisartan With or Without Hydrochlorothiazide in Patients With Mild-to-moderate Hypertension

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Telmisartan/Hydrochlorothiazide

Drug: Placebo

Drug: Telmisartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02177435

502.261

Details and patient eligibility

About

Study to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide (HCTZ) 12.5 mg (FDC 80/12.5) is superior to telmisartan 80 mg (Telm 80) alone in patients who failed to respond adequately to Telm 80 monotherapy in lowering seated trough diastolic blood pressure (DBP) after eight weeks of treatment.

Enrollment

491 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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
Ability to provide written informed consent

Exclusion criteria

Patients taking more than three anti-hypertensive medications at the screening visit
Pre-menopausal women (last menstruation ≤ 1 year prior to start of screening)
- Who are not surgically sterile (hysterectomy, tubal ligation)
- Who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study
Any women:
- Who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 4)
- Who is nursing
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- SGPT (ALT) (serum glutamate pyruvate transaminase) or SGOT (AST) (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) 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 angioedema
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 insulin treated 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 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