SMOOTH - Blood Pressure Control in Diabetic/Obese Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00239538
First received: October 14, 2005
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval at the end of a 10-week treatment period in mild-to-moderate hypertensive, overweight or obese patients with type 2 diabetes mellitus


Condition Intervention Phase
Hypertension
Diabetes Mellitus, Type 2
Drug: telmisartan combined with hydrochlorothiazide (80/12.5 mg)
Drug: valsartan combined with hydrochlorothiazide (160/12.5mg)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Open-label, Blinded Endpoint, Forced Titration Study to Compare Telmisartan Combined With HCTZ (80mg/12.5mg), to Valsartan Combined With HCTZ (160mg/12.5mg), for the Control of Mild-to-moderate Hypertension in Obese Patients With Type 2 Diabetes Mellitus Using ABPM.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline in the last 6-hour ABPM mean (relative to dose time) pulse pressure. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in the 24-hour ABPM mean (relative to dose time) for SBP, DBP and pulse pressure. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in the ABPM mean (relative to clock time) for SBP, DBP, and pulse pressure during the morning, daytime and night time periods of the 24-hour dosing interval. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in SBP and DBP load during the 24-hour dosing interval. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Responder rates based on the 24-hour ABPM mean (relative to dose time) blood pressures defined [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • In-clinic trough cuff blood pressure measures at the end of both a 4-week (Visit 4) treatment period and a 10-week (Visit 6) treatment period. [ Time Frame: 4 weeks and 10 weeks ] [ Designated as safety issue: No ]
  • Responder rates based on the mean seated trough cuff measurements [ Time Frame: 4 weeks and 10 weeks ] [ Designated as safety issue: No ]
  • Metabolic and inflammatory marker changes from baseline [ Time Frame: up to 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 840
Study Start Date: January 2003
Estimated Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to provide written informed consent.
  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:

  1. 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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239538

  Hide Study Locations
Locations
United States, Alabama
Cooper Green Hospital
Birmingham, Alabama, United States, 35223
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States, 35294-2041
Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States, 35801
Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States, 85306
Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States, 85712
United States, California
Memorial Research Medical Clinic
Long Beach, California, United States, 90806
1200
Los Angeles, California, United States, 90033
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States, 90057
8615
Nuena Park, California, United States, 90620
Boehringer Ingelheim Investigational Site
Orange, California, United States, 92868
Boehringer Ingelheim Investigational Site
Sacramento, California, United States, 95841
Boehringer Ingelheim Investigational Site
Sacramento, California, United States, 95825
595
San Francisco, California, United States, 94132
1805
Stockton, California, United States, 95204
Boehringer Ingelheim Investigational Site
Torrance, California, United States, 90505
United States, District of Columbia
2311
Washington, District of Columbia, United States, 20037
United States, Florida
Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States, 33308
Boehringer Ingelheim Investigational Site
Ft. Lauderdale, Florida, United States, 33308-4311
6448
Hollywood, Florida, United States, 33023
Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States, 32901
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States, 33027
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States, 33028
Attention: Larry I. Gilderman, D.O.
Pembroke Pines, Florida, United States, 33024
Boehringer Ingelheim Investigational Site
Pinellas Park, Florida, United States, 33781
Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Illinois
Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States, 60612
Herron Medical Center, Ltd.
Chicago, Illinois, United States, 60610
Boehringer Ingelheim Investigational Site
Orland Park, Illinois, United States, 60462
United States, Indiana
Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States, 47713
Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States, 47710
United States, Kansas
Boehringer Ingelheim Investigational Site
Shawnee, Kansas, United States, 66216
Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States, 67212
United States, Louisiana
Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States, 70119
United States, Maryland
Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States, 21204
200
Baltimore, Maryland, United States, 21218
United States, Missouri
Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States, 64114
12401
St.Louis, Missouri, United States, 63141
United States, Montana
Boehringer Ingelheim Investigational Site
Missoula, Montana, United States, 59802
United States, New York
Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States, 11203
3
Buffalo, New York, United States, 14209
United States, North Carolina
Comprehensive Clinical Research
Berlin, North Carolina, United States, 08009
Boehringer Ingelheim Investigational Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Boehringer Ingelheim Investigational Site
Kettering, Ohio, United States, 45429
Boehringer Ingelheim Investigational Site
Marion, Ohio, United States, 43302
United States, Oklahoma
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States, 73132-4904
United States, Oregon
Boehringer Ingelheim Investigational Site
Portland, Oregon, United States, 97232
United States, Pennsylvania
Boehringer Ingelheim Investigational Site
Broomal, Pennsylvania, United States, 19008
United States, Tennessee
6605
Bartlett, Tennessee, United States, 38134
108
Fayetteville, Tennessee, United States, 37334
United States, Texas
Boehringer Ingelheim Investigational Site
Carrollton, Texas, United States, 75006
7777
Dallas, Texas, United States, 75230
Boehringer Ingelheim Investigational Site
El Paso, Texas, United States, 79912
Team Research of Texas
Harker Heights, Texas, United States, 76548
Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States, 78217
Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States, 78229-4801
United States, Utah
420
Salt Lake City, Utah, United States, 84111
United States, Virginia
20901
Ettrick, Virginia, United States, 23803
United States, Washington
Boehringer Ingelheim Investigational Site
Spokane, Washington, United States, 99207
United States, Wisconsin
5000
Miwaukee, Wisconsin, United States, 53295
Argentina
Boehringer Ingelheim Investigational Site
BsAs, Argentina, C1425AST
Boehringer Ingelheim Investigational Site
Coronel Suárez, Argentina, 7540
Boehringer Ingelheim Investigational Site
Rosario, Sta. Fe, Argentina, 2000
Australia, Queensland
Boehringer Ingelheim Investigational Site
Kippa-Ring, Queensland, Australia, 4021
Australia, Victoria
Emeritus Research
Malvern, Victoria, Australia, 3144
Boehringer Ingelheim Investigational Site
Prahran, Victoria, Australia, 3181
Canada, Alberta
Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Boehringer Ingelheim Investigational Site
Conquitlam, British Columbia, Canada, V3K 3V9
Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y8
Dr. Hugh Tildesley
Vancouver, British Columbia, Canada, V6E 1M7
Canada, Newfoundland and Labrador
Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada, A1N 2C3
Canada, Nova Scotia
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada, L8M 1K7
Boehringer Ingelheim Investigational Site
Kitchener, Ontario, Canada, N2H 2P2
Boehringer Ingelheim Investigational Site
London, Ontario, Canada, N6G 2V2
Boehringer Ingelheim Investigational Site
London, Ontario, Canada, N6G 2M3
Boehringer Ingelheim Investigational Site
Mississauga, Ontario, Canada, L5K 2N6
Boehringer Ingelheim Investigational Site
North York, Ontario, Canada, M3J 1N2
Boehringer Ingelheim Investigational Site
Oakville, Ontario, Canada, L6H 3P1
Boehringer Ingelheim Investigational Site
Orleans, Ontario, Canada, K1C 1S6
Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
LMC Thornhill
Thornhill, Ontario, Canada, L4J 1V8
Boehringer Ingelheim Investigational Site
Thunder Bay, Ontario, Canada, P7E 6E7
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada, M4R 2G4
Canada, Quebec
91 Thomas-Chapais
Boucherville, Quebec, Canada, J4B 6P3
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada, H2W 1T7
Pavillon St. Sacrement
Sainte-Foy, Quebec, Canada, G1S 4L8
Canada, Saskatchewan
c/o Hemodynamics Offices
Saskatoon, Saskatchewan, Canada, S7N 0W8
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 7H9
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 3H3
Korea, Republic of
Inje University Pusan Hospital
Busan, Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of, 705717
Korea University Medical Center
Seoul, Korea, Republic of, 136705
Mexico
Boehringer Ingelheim Investigational Site
Col. Del Valle, Mexico, CP 03100
Boehringer Ingelheim Investigational Site
Col. Magdalena de las Salinas, Mexico, C.P 07300
Boehringer Ingelheim Investigational Site
Col. Sección 16, México, D.F., Mexico, C.P. 14000
Boehringer Ingelheim Investigational Site
Guadalajara, Jalisco, Mexico, C.P 44700
Boehringer Ingelheim Investigational Site
Zapopan, Jalisco, Mexico, 45100
New Zealand
Boehringer Ingelheim Investigational Site
Auckland, New Zealand
1st Floor Hagely Hostel
Christchurch, New Zealand
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Canada Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00239538     History of Changes
Other Study ID Numbers: 502.399
Study First Received: October 14, 2005
Last Updated: November 7, 2013
Health Authority: Canada: Therapeutic Products Directorate
U.S.A.: Food & Drug Administration
Mexico: Federal Commission for the Protection against Sanitary Risk
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Australia/New Zealand: Therapeutic Goods Administration/New Zealand Medicines and Medical Devices Safety Authority

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Valsartan
Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 27, 2014