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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02177435
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan Drug: Telmisartan/Hydrochlorothiazide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 491 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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 Start Date : February 1999
Actual Primary Completion Date : September 1999

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telmisartan plus Hydrochlorothiazide Drug: Telmisartan/Hydrochlorothiazide
Drug: Placebo
Experimental: Telmisartan Drug: Telmisartan
Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline in seated diastolic blood pressure (DBP) at trough [ Time Frame: Baseline (day 0), day 28, day 56 ]

Secondary Outcome Measures :
  1. Change from baseline in seated systolic blood pressure (SBP) at trough [ Time Frame: Baseline (day 0), day 28, day 56 ]
  2. Change from baseline in standing DBP and SBP at trough [ Time Frame: Baseline (day 0), day 28, day 56 ]
  3. Blood pressure control (seated DBP < 90 mmHg) [ Time Frame: 16 weeks ]
  4. Systolic blood pressure response [ Time Frame: 16 weeks ]
  5. Number of patients with abnormal findings in physical examination [ Time Frame: Baseline (screening), day 0 and day 56 ]
  6. Changes from baseline in heart rate [ Time Frame: Baseline (screening), day -56, -28, 0, 28 and 56 ]
  7. Number of patients with abnormal changes in laboratory parameters [ Time Frame: Baseline (screening), day 0 and day 56 ]
  8. Number of patients with abnormal changes in resting 12-lead ECG (electrocardiogram) [ Time Frame: Baseline (screening), day 0 and day 56 ]
  9. Orthostatic changes in blood pressure [ Time Frame: Baseline (screening), day -56, -28, 0, 28 and 56 ]
  10. Number of patients with adverse events [ Time Frame: up to 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Boehringer Ingelheim Identifier: NCT02177435     History of Changes
Other Study ID Numbers: 502.261
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists