SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
NCT ID: NCT00239538
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
840 participants
INTERVENTIONAL
2003-01-31
2004-12-31
Brief Summary
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Detailed Description
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Prospective, randomised, open-label, blinded end-point, forced-titration, parallel group comparison using Ambulatory Blood Pressure Monitoring (ABPM).
Planned/Actual Number of Subjects:
Enrolled: 1500/2085; Randomised: 750/840; Complete: 680/752
Diagnosis and Main Criteria for Inclusion:
1\) Mild-to-moderate hypertension defined as a baseline mean seated cuff DBP of 95 - 109 (inclusive) mmHg, and/or SBP of 140-179 (inclusive) mmHg, and a baseline 24-hour ABPM mean DBP \>= 85 mmHg, and/or SBP \>= 130 mmHg. 2) Overweight or obese as defined by a Body Mass Index (BMI) \>= 27 kg/m2 in non-Asians and \>= 24 kg/m2 in Asians 3) Type-2 diabetes mellitus. 4) At least 30 years of age.
Duration of Treatment:
10 weeks total: telmisartan (80 mg) or valsartan (160 mg) for 4 weeks followed by telmisartan (80 mg) plus hydrochlorothiazide (12.5 mg) or valsartan (160 mg) plus hydrochlorothiazide (12.5 mg) for an additional 6 weeks.
Criteria for Efficacy:
Primary Endpoint:
Reductions in blood pressure during the last 6 hours of the 24-hour dosing interval as measured by ABPM. The primary analysis will consist of comparing telmisartan combined with hydrochlorothiazide 80 mg/12.5 mg to valsartan combined with hydrochlorothiazide 160 mg/12.5 mg at the end of the 10-week study using a closed testing procedure first testing for non-inferiority based on SBP; if significant, testing for non-inferiority based on DBP; if significant, testing for superiority based on SBP; and if significant, testing for superiority based on DBP.
Secondary Endpoints:
Statistically greater reductions in ambulatory blood pressure for patients treated with telmisartan combined with hydrochlorothiazide 80 mg/12.5 mg compared to patients treated with valsartan combined with hydrochlorothiazide 160 mg/12.5 mg at the end of the 10-week study as measured by: 1) Changes from baseline in the last 6 hours of the 24-hour dosing interval for pulse pressure; 2) Changes from baseline in the 24-hour ABPM mean (relative to dose time) for SBP, DBP, and pulse pressure; 3) Changes from baseline in the ABPM mean SBP, DBP, and pulse pressure (relative to clock time) during other periods (i.e., morning, daytime, night time) of the 24-hour dosing interval; 4) Change from baseline in systolic and diastolic blood pressure load during the 24-hour dosing interval; and 5) Percentage of patients responding to treatment based on the 24-hour ABPM mean SBP and DBP (relative to dose time).
Statistically greater reduction in mean seated trough blood pressure patients treated with telmisartan combined with hydrochlorothiazide 80 mg/12.5 mg compared to patients treated with valsartan combined with hydrochlorothiazide 160 mg/12.5 mg at the end of the 10-week study as measured by: 1) Changes from baseline in mean seated trough SBP and DBP as determined by electronic or manual device in-clinic; and 2) Percentage of patients responding to treatment based on electronic or manual in-clinic trough cuff blood pressures.
Evaluation of other endpoints comparing telmisartan combined with hydrochlorothiazide 80 mg/12.5 mg to valsartan combined with hydrochlorothiazide 160 mg/12.5 mg, respectively, including: 1) Changes from baseline in metabolic markers: serum TG, LDL-C, HDL-C, total cholesterol, potassium, fasting glucose and HbA1C, and for urine: Na, K, Cl, proteinuria (as measured by spot urine for protein:creatinine ratio); and 2) inflammatory markers: serum high sensitive C-reactive protein, serum homocysteine and plasma fibrinogen.
Criteria for Safety:
Evaluation of adverse events, physical examinations, laboratory assessments, pulse rate and cuff blood pressure monitoring.
Statistical Method:
Analysis of covariance with treatment and centre as main effects and baseline as a covariate; Mantel-Haenszel test controlling for centre.
Study Hypothesis:
Null Hypothesis:
The overall mean change from baseline in the automated blood pressure monitor mean blood pressure during the last 6 hours of the 24-hour dosing interval for telmisartan (80 mg) plus hydrochlorothiazide (12.5 mg) is less than or equal to that for valsartan (160 mg) plus hydrochlorothiazide (12.5 mg).
Alternative Hypothesis:
The overall mean change from baseline in the automated blood pressure monitor mean blood pressure during the last 6 hours of the 24-hour dosing interval for telmisartan (80 mg) plus hydrochlorothiazide (12.5 mg) is greater than that for valsartan (160 mg) plus hydrochlorothiazide (12.5 mg).
Comparison(s):
Telmisartan (80 mg) plus hydrochlorothiazide (12.5 mg) vs. valsartan (160 mg) plus hydrochlorothiazide (12.5 mg)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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telmisartan combined with hydrochlorothiazide (80/12.5 mg)
valsartan combined with hydrochlorothiazide (160/12.5mg)
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 24-hour mean DBP of \>= 85 mmHg, and/or SBP = 130 mmHg, measured by ABPM at Visit 3.
4. 30 years of age or greater.
5. Ability to stop current antihypertensive therapy and other disallowed medications without risk to the patient.
6. Diagnosis of type-2 diabetes mellitus with HbA1C less than or equal to 10%.
7. Overweight or obese as defined by a BMI \>= 27 kg/m2 in non-Asians and \>= 24 kg/m2 in Asians.
8. Negative UPT for females.
Exclusion Criteria
2. Night shift workers
3. Mean sitting SBP \>= 180 mmHg or mean sitting DBP \>= 110 mmHg during any visit of the placebo run-in period.
4. Known or suspected secondary hypertension. Hepatic and/or renal dysfunction
5. Fasting serum glucose \> 17 mmol/l (or 300 mg/dl) at visit 2
6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients on dialysis or post-renal transplant patients.
7. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
8. Uncorrected volume depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders (e.g., cholestasis).
12. Congestive heart failure
13. Stroke within the past six months.
14. Documented severe obstructive coronary artery disease.
15. Myocardial infarction, cardiac surgery or unstable angina within the past three months.
16. PCI (percutaneous coronary intervention) within the past three months or planned during trial period.
17. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias.
18. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
19. Patients with type-1 diabetes mellitus.
20. Patients who have previously experienced symptoms of angioedema during ACE or ARB treatment.
21. History of drug or alcohol dependency in past six months.
22. Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
23. Any investigational drug therapy within the past month.
24. Known hypersensitivity to any component of the study drug.
25. Concurrent use of corticosteroids, colestipol or cholestyramine resins.
26. Any clinical condition which would not allow safe completion of the protocol.
27. Inability to comply with the protocol.
28. Any surgery that is, at the time of screening, planned to take place during the study period.
29. History of non-compliance with prescribed medications.
30 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
B.I. Canada Ltd.
Locations
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Cooper Green Hospital
Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States
Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
Memorial Research Medical Clinic
Long Beach, California, United States
1200
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
8615
Nuena Park, California, United States
Boehringer Ingelheim Investigational Site
Orange, California, United States
Boehringer Ingelheim Investigational Site
Sacramento, California, United States
Boehringer Ingelheim Investigational Site
Sacramento, California, United States
595
San Francisco, California, United States
1805
Stockton, California, United States
Boehringer Ingelheim Investigational Site
Torrance, California, United States
2311
Washington D.C., District of Columbia, United States
Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
6448
Hollywood, Florida, United States
Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
Attention: Larry I. Gilderman, D.O.
Pembroke Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Pinellas Park, Florida, United States
Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States
Herron Medical Center, Ltd.
Chicago, Illinois, United States
Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
Boehringer Ingelheim Investigational Site
Orland Park, Illinois, United States
Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
Boehringer Ingelheim Investigational Site
Shawnee, Kansas, United States
Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
200
Baltimore, Maryland, United States
Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
12401
St Louis, Missouri, United States
Boehringer Ingelheim Investigational Site
Missoula, Montana, United States
Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States
3
Buffalo, New York, United States
Comprehensive Clinical Research
Bina, North Carolina, United States
Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
Boehringer Ingelheim Investigational Site
Kettering, Ohio, United States
Boehringer Ingelheim Investigational Site
Marion, Ohio, United States
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
Boehringer Ingelheim Investigational Site
Broomal, Pennsylvania, United States
6605
Bartlett, Tennessee, United States
108
Fayetteville, Tennessee, United States
Boehringer Ingelheim Investigational Site
Carrollton, Texas, United States
7777
Dallas, Texas, United States
Boehringer Ingelheim Investigational Site
El Paso, Texas, United States
Team Research of Texas
Harker Heights, Texas, United States
Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
420
Salt Lake City, Utah, United States
20901
Ettrick, Virginia, United States
Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
5000
Miwaukee, Wisconsin, United States
Boehringer Ingelheim Investigational Site
BsAs, , Argentina
Boehringer Ingelheim Investigational Site
Coronel Suárez, , Argentina
Boehringer Ingelheim Investigational Site
Rosario, Santa Fe, , Argentina
Boehringer Ingelheim Investigational Site
Kippa-Ring, Queensland, Australia
Emeritus Research
Malvern, Victoria, Australia
Boehringer Ingelheim Investigational Site
Prahran, Victoria, Australia
Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
Boehringer Ingelheim Investigational Site
Conquitlam, British Columbia, Canada
Dr. Hugh Tildesley
Vancouver, British Columbia, Canada
Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada
Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
Boehringer Ingelheim Investigational Site
Kitchener, Ontario, Canada
Boehringer Ingelheim Investigational Site
London, Ontario, Canada
Boehringer Ingelheim Investigational Site
London, Ontario, Canada
Boehringer Ingelheim Investigational Site
Mississauga, Ontario, Canada
Boehringer Ingelheim Investigational Site
North York, Ontario, Canada
Boehringer Ingelheim Investigational Site
Oakville, Ontario, Canada
Boehringer Ingelheim Investigational Site
Orléans, Ontario, Canada
Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada
LMC Thornhill
Thornhill, Ontario, Canada
Boehringer Ingelheim Investigational Site
Thunder Bay, Ontario, Canada
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
91 Thomas-Chapais
Boucherville, Quebec, Canada
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Pavillon St. Sacrement
Sainte-Foy, Quebec, Canada
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
c/o Hemodynamics Offices
Saskatoon, Saskatchewan, Canada
Boehringer Ingelheim Investigational Site
Col. Magdalena de Las Salinas, , Mexico
Boehringer Ingelheim Investigational Site
Col. Sección 16, México, D.F., , Mexico
Boehringer Ingelheim Investigational Site
Colonia del Valle, , Mexico
Boehringer Ingelheim Investigational Site
Guadalajara, Jalisco, , Mexico
Boehringer Ingelheim Investigational Site
Zapopan, Jalisco, , Mexico
Boehringer Ingelheim Investigational Site
Auckland, , New Zealand
1st Floor Hagely Hostel
Christchurch, , New Zealand
Inje University Pusan Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Korea University Medical Center
Seoul, , South Korea
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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502.399
Identifier Type: -
Identifier Source: org_study_id