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Status:

COMPLETED

SMOOTH - Blood Pressure Control in Diabetic/Obese Patients

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Hypertension

Diabetes Mellitus, Type 2

Eligibility:

All Genders

30+ years

Phase:

PHASE4

Brief Summary

The primary objective of this study is to demonstrate that telmisartan 80 mg combined with hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to valsartan 160 mg co...

Detailed Description

Methodology: Prospective, randomised, open-label, blinded end-point, forced-titration, parallel group comparison using Ambulatory Blood Pressure Monitoring (ABPM). Planned/Actual Number of Subjects:...

Eligibility Criteria

Inclusion

  • Ability to provide written informed consent.
  • Hypertension defined as a mean seated DBP of 95-109 (inclusive) mmHg, and/or SBP of 140-179 (inclusive) mmHg, measured by BpTRU electronic or manual cuff at Visit 2.
  • 24-hour mean DBP of \>= 85 mmHg, and/or SBP = 130 mmHg, measured by ABPM at Visit 3.
  • 30 years of age or greater.
  • Ability to stop current antihypertensive therapy and other disallowed medications without risk to the patient.
  • Diagnosis of type-2 diabetes mellitus with HbA1C less than or equal to 10%.
  • Overweight or obese as defined by a BMI \>= 27 kg/m2 in non-Asians and \>= 24 kg/m2 in Asians.
  • Negative UPT for females.

Exclusion

  • Pre-menopausal women, not surgically sterile or, not nursing/pregnant or are of child-bearing potential and will not practice acceptable methods of birth control during study.
  • Night shift workers
  • Mean sitting SBP \>= 180 mmHg or mean sitting DBP \>= 110 mmHg during any visit of the placebo run-in period.
  • Known or suspected secondary hypertension. Hepatic and/or renal dysfunction
  • Fasting serum glucose \> 17 mmol/l (or 300 mg/dl) at visit 2
  • Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients on dialysis or post-renal transplant patients.
  • Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
  • Uncorrected volume depletion.
  • Primary aldosteronism.
  • Hereditary fructose intolerance.
  • Biliary obstructive disorders (e.g., cholestasis).
  • Congestive heart failure
  • Stroke within the past six months.
  • Documented severe obstructive coronary artery disease.
  • Myocardial infarction, cardiac surgery or unstable angina within the past three months.
  • PCI (percutaneous coronary intervention) within the past three months or planned during trial period.
  • Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias.
  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
  • Patients with type-1 diabetes mellitus.
  • Patients who have previously experienced symptoms of angioedema during ACE or ARB treatment.
  • History of drug or alcohol dependency in past six months.
  • Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
  • Any investigational drug therapy within the past month.
  • Known hypersensitivity to any component of the study drug.
  • Concurrent use of corticosteroids, colestipol or cholestyramine resins.
  • Any clinical condition which would not allow safe completion of the protocol.
  • Inability to comply with the protocol.
  • Any surgery that is, at the time of screening, planned to take place during the study period.
  • History of non-compliance with prescribed medications.

Key Trial Info

Start Date :

January 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2004

Estimated Enrollment :

840 Patients enrolled

Trial Details

Trial ID

NCT00239538

Start Date

January 1 2003

End Date

December 1 2004

Last Update

November 8 2013

Active Locations (102)

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Page 1 of 26 (102 locations)

1

Cooper Green Hospital

Birmingham, Alabama, United States, 35223

2

Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States, 35294-2041

3

Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States, 35801

4

Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States, 36608