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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.
First Received: October 14, 2005   Last Updated: July 6, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00240474
  Purpose

The primary objective of this clinical trial was to show that the combination of telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg was not inferior to and was possibly superior to amlodipine 10 mg + HCTZ 12.5 mg in reducing the systolic blood pressure (SBP) in the last six hours of the 24-hour dose period [as measured by 24-hour ambulatory blood pressure monitoring ( ABPM)] in elderly patients with predominantly systolic hypertension. The primary endpoint was the change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM) at the end-of-study visit.


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

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Pharmaceuticals:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 850
Study Start Date: November 2002
Estimated Study Completion Date: March 2004
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240474

  Show 73 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BIL UK / Ireland
  More Information

Additional Information:
No publications provided

Study ID Numbers: 502.400
Study First Received: October 14, 2005
Last Updated: July 6, 2009
ClinicalTrials.gov Identifier: NCT00240474     History of Changes
Health Authority: Belgium: Directorate General for Medicinal Products;   Denmark: Laegemiddelstyrelsen Clinical Studies;   Finland: Lääkelaitos, National Agency for Medicines;   France: French Medicine Agency (AFSSAPS);   Germany: Bundesministerium für Arzneimittel und Medizinprodukte;   Ireland: Irish Medicines Board;   Italy: Comitato Etico dell'Azienda Ospedaliera "Arcispedale Sant'Anna" - Università di Ferrara;   Netherlands: No regulatory agency approval needed for clinical trials;   South Africa: Medicines Control Council;   Spain: Agencia Española del Medicamento

Study placed in the following topic categories:
Vasodilator Agents
Diuretics
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Hydrochlorothiazide
Protease Inhibitors
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Angiotensin-Converting Enzyme Inhibitors
Telmisartan
Hypertension

Additional relevant MeSH terms:
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Protease Inhibitors
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009