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

An Eight Week Randomized, Double-Blind Study Comparing a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 80 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: Telmisartan; Drug: Telmisartan/Hydrochlorothiazide

• Study Type: Interventional
• Enrollment (Actual): 491
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Telmisartan plus Hydrochlorothiazide	Drug: Placebo; Drug: Telmisartan/Hydrochlorothiazide
EXPERIMENTAL: Telmisartan	Drug: Placebo; Drug: Telmisartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in seated diastolic blood pressure (DBP) at trough	Baseline (day 0), day 28, day 56

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	up to 16 weeks
Change from baseline in seated systolic blood pressure (SBP) at trough	Baseline (day 0), day 28, day 56
Change from baseline in standing DBP and SBP at trough	Baseline (day 0), day 28, day 56
Blood pressure control (seated DBP < 90 mmHg)	16 weeks
Systolic blood pressure response	16 weeks
Number of patients with abnormal findings in physical examination	Baseline (screening), day 0 and day 56
Changes from baseline in heart rate	Baseline (screening), day -56, -28, 0, 28 and 56
Number of patients with abnormal changes in laboratory parameters	Baseline (screening), day 0 and day 56
Number of patients with abnormal changes in resting 12-lead ECG (electrocardiogram)	Baseline (screening), day 0 and day 56
Orthostatic changes in blood pressure	Baseline (screening), day -56, -28, 0, 28 and 56

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 1999
• Primary Completion (ACTUAL): September 1, 1999

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (ESTIMATE): June 27, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Telmisartan; Telmisartan, hydrochlorothiazide drug combination
• Other Study ID Numbers: 502.261