SMOOTH - Blood Pressure Control in Diabetic/Obese Patients

NCT00239538 | Completed Phase 4

• 1 other identifier: 502.399
• Study Type: interventional
• Target: 840
• Locations: 8 countries
• Sites: 102

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 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

Conditions

Hypertension; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM)

  10 weeks

Secondary Outcomes (8)

• Changes from baseline in the last 6-hour ABPM mean (relative to dose time) pulse pressure.

  10 weeks

• Changes from baseline in the 24-hour ABPM mean (relative to dose time) for SBP, DBP and pulse pressure.

  10 weeks

• 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.

  10 weeks

• Changes from baseline in SBP and DBP load during the 24-hour dosing interval.

  10 weeks

• Responder rates based on the 24-hour ABPM mean (relative to dose time) blood pressures defined

  10 weeks

Interventions

telmisartan combined with hydrochlorothiazide (80/12.5 mg) DRUG

valsartan combined with hydrochlorothiazide (160/12.5mg) DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• hour mean DBP of \>= 85 mmHg, and/or SBP = 130 mmHg, measured by ABPM at Visit 3.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (102)

Cooper Green Hospital

Birmingham, Alabama, 35223, United States

Location

Boehringer Ingelheim Investigational Site

Birmingham, Alabama, 35294-2041, United States

Location

Boehringer Ingelheim Investigational Site

Huntsville, Alabama, 35801, United States

Location

Boehringer Ingelheim Investigational Site

Mobile, Alabama, 36608, United States

Location

Boehringer Ingelheim Investigational Site

Glendale, Arizona, 85306, United States

Location

Boehringer Ingelheim Investigational Site

Tucson, Arizona, 85712, United States

Location

Memorial Research Medical Clinic

Long Beach, California, 90806, United States

Location

1200

Los Angeles, California, 90033, United States

Location

Boehringer Ingelheim Investigational Site

Los Angeles, California, 90057, United States

Location

8615

Nuena Park, California, 90620, United States

Location

Boehringer Ingelheim Investigational Site

Orange, California, 92868, United States

Location

Boehringer Ingelheim Investigational Site

Sacramento, California, 95825, United States

Location

Boehringer Ingelheim Investigational Site

Sacramento, California, 95841, United States

Location

595

San Francisco, California, 94132, United States

Location

1805

Stockton, California, 95204, United States

Location

Boehringer Ingelheim Investigational Site

Torrance, California, 90505, United States

Location

2311

Washington D.C., District of Columbia, 20037, United States

Location

Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, 33308-4311, United States

Location

Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

6448

Hollywood, Florida, 33023, United States

Location

Boehringer Ingelheim Investigational Site

Melbourne, Florida, 32901, United States

Location

Attention: Larry I. Gilderman, D.O.

Pembroke Pines, Florida, 33024, United States

Location

Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, 33027, United States

Location

Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, 33028, United States

Location

Boehringer Ingelheim Investigational Site

Pinellas Park, Florida, 33781, United States

Location

Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, 33401, United States

Location

Herron Medical Center, Ltd.

Chicago, Illinois, 60610, United States

Location

Boehringer Ingelheim Investigational Site

Chicago, Illinois, 60612, United States

Location

Boehringer Ingelheim Investigational Site

Orland Park, Illinois, 60462, United States

Location

Boehringer Ingelheim Investigational Site

Evansville, Indiana, 47710, United States

Location

Boehringer Ingelheim Investigational Site

Evansville, Indiana, 47713, United States

Location

Boehringer Ingelheim Investigational Site

Shawnee, Kansas, 66216, United States

Location

Boehringer Ingelheim Investigational Site

Wichita, Kansas, 67212, United States

Location

Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, 70119, United States

Location

Boehringer Ingelheim Investigational Site

Baltimore, Maryland, 21204, United States

Location

200

Baltimore, Maryland, 21218, United States

Location

Boehringer Ingelheim Investigational Site

Kansas City, Missouri, 64114, United States

Location

12401

St Louis, Missouri, 63141, United States

Location

Boehringer Ingelheim Investigational Site

Missoula, Montana, 59802, United States

Location

Boehringer Ingelheim Investigational Site

Brooklyn, New York, 11203, United States

Location

3

Buffalo, New York, 14209, United States

Location

Comprehensive Clinical Research

Bina, North Carolina, 08009, United States

Location

Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Boehringer Ingelheim Investigational Site

Kettering, Ohio, 45429, United States

Location

Boehringer Ingelheim Investigational Site

Marion, Ohio, 43302, United States

Location

Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, 73132-4904, United States

Location

Boehringer Ingelheim Investigational Site

Portland, Oregon, 97232, United States

Location

Boehringer Ingelheim Investigational Site

Broomal, Pennsylvania, 19008, United States

Location

6605

Bartlett, Tennessee, 38134, United States

Location

108

Fayetteville, Tennessee, 37334, United States

Location

Boehringer Ingelheim Investigational Site

Carrollton, Texas, 75006, United States

Location

7777

Dallas, Texas, 75230, United States

Location

Boehringer Ingelheim Investigational Site

El Paso, Texas, 79912, United States

Location

Team Research of Texas

Harker Heights, Texas, 76548, United States

Location

Boehringer Ingelheim Investigational Site

San Antonio, Texas, 78217, United States

Location

Boehringer Ingelheim Investigational Site

San Antonio, Texas, 78229-4801, United States

Location

420

Salt Lake City, Utah, 84111, United States

Location

20901

Ettrick, Virginia, 23803, United States

Location

Boehringer Ingelheim Investigational Site

Spokane, Washington, 99207, United States

Location

5000

Miwaukee, Wisconsin, 53295, United States

Location

Boehringer Ingelheim Investigational Site

BsAs, C1425AST, Argentina

Location

Boehringer Ingelheim Investigational Site

Coronel Suárez, 7540, Argentina

Location

Boehringer Ingelheim Investigational Site

Rosario, Santa Fe, 2000, Argentina

Location

Boehringer Ingelheim Investigational Site

Kippa-Ring, Queensland, 4021, Australia

Location

Emeritus Research

Malvern, Victoria, 3144, Australia

Location

Boehringer Ingelheim Investigational Site

Prahran, Victoria, 3181, Australia

Location

Boehringer Ingelheim Investigational Site

Calgary, Alberta, T2N 2T9, Canada

Location

Boehringer Ingelheim Investigational Site

Conquitlam, British Columbia, V3K 3V9, Canada

Location

Dr. Hugh Tildesley

Vancouver, British Columbia, V6E 1M7, Canada

Location

Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, V6Z 1Y8, Canada

Location

Boehringer Ingelheim Investigational Site

Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

Location

Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, A1N 2C3, Canada

Location

Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, B3H2Y9, Canada

Location

Boehringer Ingelheim Investigational Site

Hamilton, Ontario, L8M 1K7, Canada

Location

Boehringer Ingelheim Investigational Site

Kitchener, Ontario, N2H 2P2, Canada

Location

Boehringer Ingelheim Investigational Site

London, Ontario, N6G 2M3, Canada

Location

Boehringer Ingelheim Investigational Site

London, Ontario, N6G 2V2, Canada

Location

Boehringer Ingelheim Investigational Site

Mississauga, Ontario, L5K 2N6, Canada

Location

Boehringer Ingelheim Investigational Site

North York, Ontario, M3J 1N2, Canada

Location

Boehringer Ingelheim Investigational Site

Oakville, Ontario, L6H 3P1, Canada

Location

Boehringer Ingelheim Investigational Site

Orléans, Ontario, K1C 1S6, Canada

Location

Boehringer Ingelheim Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

Location

LMC Thornhill

Thornhill, Ontario, L4J 1V8, Canada

Location

Boehringer Ingelheim Investigational Site

Thunder Bay, Ontario, P7E 6E7, Canada

Location

Boehringer Ingelheim Investigational Site

Toronto, Ontario, M4R 2G4, Canada

Location

91 Thomas-Chapais

Boucherville, Quebec, J4B 6P3, Canada

Location

Boehringer Ingelheim Investigational Site

Montreal, Quebec, H2W 1T7, Canada

Location

Pavillon St. Sacrement

Sainte-Foy, Quebec, G1S 4L8, Canada

Location

Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, S7K 3H3, Canada

Location

Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, S7K 7H9, Canada

Location

c/o Hemodynamics Offices

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Boehringer Ingelheim Investigational Site

Col. Magdalena de Las Salinas, C.P 07300, Mexico

Location

Boehringer Ingelheim Investigational Site

Col. Sección 16, México, D.F., C.P. 14000, Mexico

Location

Boehringer Ingelheim Investigational Site

Colonia del Valle, CP 03100, Mexico

Location

Boehringer Ingelheim Investigational Site

Guadalajara, Jalisco, C.P 44700, Mexico

Location

Boehringer Ingelheim Investigational Site

Zapopan, Jalisco, 45100, Mexico

Location

Boehringer Ingelheim Investigational Site

Auckland, New Zealand

Location

1st Floor Hagely Hostel

Christchurch, New Zealand

Location

Inje University Pusan Hospital

Busan, South Korea

Location

Yeungnam University Medical Center

Daegu, 705717, South Korea

Location

Korea University Medical Center

Seoul, 136705, South Korea

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Canada Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 17, 2005
• Study Start: January 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

ME (5); TW (1); AU (3); US (60); AR (3); CA (25); NZ (2); KR (3)