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A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension (ATHOS Study)

This study has been completed.
Information provided by:
Boehringer Ingelheim Identifier:
First received: October 14, 2005
Last updated: October 31, 2013
Last verified: October 2013
The primary objective of this study was test non-inferiority of telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg in comparison to amlodipine 10 mg + HCTZ 12.5 mg in reducing ambulatory systolic blood pressure (SBP) in the last 6 hours of the 24-hour dosing interval (determined by ambulatory blood pressure monitoring: ABPM) in elderly patients with predominantly systolic hypertension.

Condition Intervention Phase
Drug: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg
Drug: Amlodipine 10 mg + hydrochlorothiazide 12.5 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Telmisartan 80 mg + Hydrochlorothiazide 12.5 mg With Amlodipine 10 mg + Hydrochlorothiazide 12.5 mg in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension. A Prospective, Randomised, Open-label, Blinded End-point Evaluation. (ATHOS Study)

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in the last 6-hour mean (relative to dose time) in SBP as measured by 24-hour ABPM at the end-of-study visit [ Time Frame: 14 weeks ]

Secondary Outcome Measures:
  • Change from baseline in DBP in the last six hours of the 24-hour dose period [ Time Frame: week 8 and 14 ]
  • Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period [ Time Frame: week 8 and 14 ]
  • Change from baseline SBP and DBP for other time intervals ( i.e. 24-hour mean, morning mean (06:00-11:59), daytime mean (06:00-21:59), and night-time mean (22:00-05:59)) [ Time Frame: week 8 and 14 ]
  • Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index. [ Time Frame: week 8 and 14 ]
  • Change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM). [ Time Frame: 8 weeks ]
  • Proportion of patients achieving a target response in SBP [ Time Frame: 14 weeks ]
  • Proportion of patients achieving SBP control [ Time Frame: 14 weeks ]
  • Proportion of patients achieving normal blood pressure [ Time Frame: 14 weeks ]
  • Proportion of patients achieving high-normal blood pressure [ Time Frame: 14 weeks ]
  • Change from baseline in trough seated SBP [ Time Frame: 14 weeks ]
  • Change from baseline in trough seated DBP [ Time Frame: 14 weeks ]
  • Safety and tolerability of the combination of telmisartan 80 mg and HCTZ 12.5 mg compared with amlodipine 10 mg and HCTZ 12.5 mg [ Time Frame: 14 weeks ]

Estimated Enrollment: 1000
Study Start Date: December 2002
Estimated Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • aged at least 60 years old
  • mean SBP greater than 140 mmHg and mean DBP less than or equal to 95 mmHg
  • 24-hour mean ambulatory SBP greater than 125 mmHg
  • hypertensive patients not on current antihypertensive therapy or able to stop their current treatment for a period of up to eighteen weeks
  • willing and able to provide written informed consent

Exclusion criteria:

  • women of child-bearing potential who are NOT practicing acceptable means of birth control
  • known or suspected secondary hypertension
  • mean SBP equal to or greater than 200 mmHg
  • hepatic and/or renal dysfunction as defined by the following laboratory parameters:

    • 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
  • patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
  • history of drug or alcohol dependency within the previous six months
  • chronic administration of any medication known to affect blood pressure, other than the trial medication
  • concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
  • symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)
  • unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent
  • stroke less than six months prior to informed consent
  • sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator
  • hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
  • insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months
  • night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4:00 AM
  • known allergic hypersensitivity to any component of the formulations under investigation
  • concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as less than 80% or more than 120%) during the run-in period
  • current treatment with any antihypertensive agent
  • any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan, amlodipine or hydrochlorothiazide
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Please refer to this study by its identifier: NCT00240474

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator BIL UK / Ireland
  More Information Identifier: NCT00240474     History of Changes
Other Study ID Numbers: 502.400
Study First Received: October 14, 2005
Last Updated: October 31, 2013

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Telmisartan, hydrochlorothiazide drug combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors processed this record on May 25, 2017