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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)

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: NCT00240474
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 1, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg Drug: Amlodipine 10 mg + hydrochlorothiazide 12.5 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2002
Actual Primary Completion Date : March 2004
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. Change from baseline in DBP in the last six hours of the 24-hour dose period [ Time Frame: week 8 and 14 ]
  2. Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period [ Time Frame: week 8 and 14 ]
  3. 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 ]
  4. Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index. [ Time Frame: week 8 and 14 ]
  5. 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 ]
  6. Proportion of patients achieving a target response in SBP [ Time Frame: 14 weeks ]
  7. Proportion of patients achieving SBP control [ Time Frame: 14 weeks ]
  8. Proportion of patients achieving normal blood pressure [ Time Frame: 14 weeks ]
  9. Proportion of patients achieving high-normal blood pressure [ Time Frame: 14 weeks ]
  10. Change from baseline in trough seated SBP [ Time Frame: 14 weeks ]
  11. Change from baseline in trough seated DBP [ Time Frame: 14 weeks ]
  12. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00240474

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Study Coordinator BIL UK / Ireland
Additional Information:
Layout table for additonal information Identifier: NCT00240474    
Other Study ID Numbers: 502.400
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists