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.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00240474
First received: October 14, 2005
Last updated: October 31, 2013
Last verified: October 2013

October 14, 2005
October 31, 2013
December 2002
March 2004   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The primary endpoint variable was the ambulatory SBP in the last six hours of the dosing interval at the end-of-study visit compared with the ambulatory SBP in the last six hours of the dosing interval at the baseline visit.
Complete list of historical versions of study NCT00240474 on ClinicalTrials.gov Archive Site
  • Change from baseline in DBP in the last six hours of the 24-hour dose period [ Time Frame: week 8 and 14 ] [ Designated as safety issue: No ]
  • Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period [ Time Frame: week 8 and 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index. [ Time Frame: week 8 and 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving a target response in SBP [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving SBP control [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving normal blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving high-normal blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in trough seated SBP [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in trough seated DBP [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Ambulatory DBP, pulse pressure in the last 6 hours of the dosing interval, ambulatory SBP, DBP and pulse pressure at other times of day, proportion of patients achieving SBP control, SBP response and normal blood pressure
Not Provided
Not Provided
 
A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension (ATHOS Study)
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg
  • Drug: Amlodipine 10 mg + hydrochlorothiazide 12.5 mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
March 2004
March 2004   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Ireland,   Belgium,   Spain,   Italy,   Germany,   Denmark,   Finland,   South Africa,   Netherlands,   France
 
NCT00240474
502.400
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator BIL UK / Ireland
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP