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HypertensionPhase 4NCT00239538

SMOOTH - Blood Pressure Control in Diabetic/Obese Patients

A Phase 4 study testing telmisartan combined with hydrochlorothiazide (80/12.5 mg) and valsartan combined with hydrochlorothiazide (160/12.5mg) in people with Hypertension and Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 102 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Hypertension, Diabetes Mellitus, Type 2
What is being tested?
telmisartan combined with hydrochlorothiazide (80/12.5 mg) and valsartan combined with hydrochlorothiazide (160/12.5mg)
How many people
840 participants
Where
102 sitesin 8 countries
Study dates
Jan 2003to Dec 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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.

Trial locations and contacts

102 sites in 8 countries.

102 sites in 8 countries

United States60 sites

  • Boehringer Ingelheim Investigational Site

    Baltimore, Maryland, 21204

  • 200

    Baltimore, Maryland, 21218

  • 6605

    Bartlett, Tennessee, 38134

  • Comprehensive Clinical Research

    Bina, North Carolina, 08009

  • Cooper Green Hospital

    Birmingham, Alabama, 35223

  • Boehringer Ingelheim Investigational Site

    Birmingham, Alabama, 35294-2041

  • Boehringer Ingelheim Investigational Site

    Brooklyn, New York, 11203

  • Boehringer Ingelheim Investigational Site

    Broomal, Pennsylvania, 19008

  • 3

    Buffalo, New York, 14209

  • Boehringer Ingelheim Investigational Site

    Carrollton, Texas, 75006

  • Herron Medical Center, Ltd.

    Chicago, Illinois, 60610

  • Boehringer Ingelheim Investigational Site

    Chicago, Illinois, 60612

  • 7777

    Dallas, Texas, 75230

  • Boehringer Ingelheim Investigational Site

    El Paso, Texas, 79912

  • 20901

    Ettrick, Virginia, 23803

  • Boehringer Ingelheim Investigational Site

    Evansville, Indiana, 47710

  • Boehringer Ingelheim Investigational Site

    Evansville, Indiana, 47713

  • 108

    Fayetteville, Tennessee, 37334

  • Boehringer Ingelheim Investigational Site

    Fort Lauderdale, Florida, 33308-4311

  • Boehringer Ingelheim Investigational Site

    Fort Lauderdale, Florida, 33308

  • Boehringer Ingelheim Investigational Site

    Glendale, Arizona, 85306

  • Team Research of Texas

    Harker Heights, Texas, 76548

  • 6448

    Hollywood, Florida, 33023

  • Boehringer Ingelheim Investigational Site

    Huntsville, Alabama, 35801

  • Boehringer Ingelheim Investigational Site

    Kansas City, Missouri, 64114

  • Boehringer Ingelheim Investigational Site

    Kettering, Ohio, 45429

  • Memorial Research Medical Clinic

    Long Beach, California, 90806

  • 1200

    Los Angeles, California, 90033

  • Boehringer Ingelheim Investigational Site

    Los Angeles, California, 90057

  • Boehringer Ingelheim Investigational Site

    Marion, Ohio, 43302

  • Boehringer Ingelheim Investigational Site

    Melbourne, Florida, 32901

  • Boehringer Ingelheim Investigational Site

    Missoula, Montana, 59802

  • 5000

    Miwaukee, Wisconsin, 53295

  • Boehringer Ingelheim Investigational Site

    Mobile, Alabama, 36608

  • Boehringer Ingelheim Investigational Site

    New Orleans, Louisiana, 70119

  • 8615

    Nuena Park, California, 90620

  • Boehringer Ingelheim Investigational Site

    Oklahoma City, Oklahoma, 73132-4904

  • Boehringer Ingelheim Investigational Site

    Orange, California, 92868

  • Boehringer Ingelheim Investigational Site

    Orland Park, Illinois, 60462

  • Attention: Larry I. Gilderman, D.O.

    Pembroke Pines, Florida, 33024

  • Boehringer Ingelheim Investigational Site

    Pembroke Pines, Florida, 33027

  • Boehringer Ingelheim Investigational Site

    Pembroke Pines, Florida, 33028

  • Boehringer Ingelheim Investigational Site

    Pinellas Park, Florida, 33781

  • Boehringer Ingelheim Investigational Site

    Portland, Oregon, 97232

  • Boehringer Ingelheim Investigational Site

    Sacramento, California, 95825

  • Boehringer Ingelheim Investigational Site

    Sacramento, California, 95841

  • 420

    Salt Lake City, Utah, 84111

  • Boehringer Ingelheim Investigational Site

    San Antonio, Texas, 78217

  • Boehringer Ingelheim Investigational Site

    San Antonio, Texas, 78229-4801

  • 595

    San Francisco, California, 94132

  • Boehringer Ingelheim Investigational Site

    Shawnee, Kansas, 66216

  • Boehringer Ingelheim Investigational Site

    Spokane, Washington, 99207

  • 12401

    St Louis, Missouri, 63141

  • 1805

    Stockton, California, 95204

  • Boehringer Ingelheim Investigational Site

    Torrance, California, 90505

  • Boehringer Ingelheim Investigational Site

    Tucson, Arizona, 85712

  • 2311

    Washington D.C., District of Columbia, 20037

  • Boehringer Ingelheim Investigational Site

    West Palm Beach, Florida, 33401

  • Boehringer Ingelheim Investigational Site

    Wichita, Kansas, 67212

  • Boehringer Ingelheim Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada25 sites

  • Boehringer Ingelheim Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • 91 Thomas-Chapais

    Boucherville, Quebec, J4B 6P3

  • Boehringer Ingelheim Investigational Site

    Calgary, Alberta, T2N 2T9

  • Boehringer Ingelheim Investigational Site

    Conquitlam, British Columbia, V3K 3V9

  • Boehringer Ingelheim Investigational Site

    Halifax, Nova Scotia, B3H2Y9

  • Boehringer Ingelheim Investigational Site

    Hamilton, Ontario, L8M 1K7

  • Boehringer Ingelheim Investigational Site

    Kitchener, Ontario, N2H 2P2

  • Boehringer Ingelheim Investigational Site

    London, Ontario, N6G 2M3

  • Boehringer Ingelheim Investigational Site

    London, Ontario, N6G 2V2

  • Boehringer Ingelheim Investigational Site

    Mississauga, Ontario, L5K 2N6

  • Boehringer Ingelheim Investigational Site

    Montreal, Quebec, H2W 1T7

  • Boehringer Ingelheim Investigational Site

    Mount Pearl, Newfoundland and Labrador, A1N 2C3

  • Boehringer Ingelheim Investigational Site

    North York, Ontario, M3J 1N2

  • Boehringer Ingelheim Investigational Site

    Oakville, Ontario, L6H 3P1

  • Boehringer Ingelheim Investigational Site

    Orléans, Ontario, K1C 1S6

  • Pavillon St. Sacrement

    Sainte-Foy, Quebec, G1S 4L8

  • Boehringer Ingelheim Investigational Site

    Sarnia, Ontario, N7T 4X3

  • Boehringer Ingelheim Investigational Site

    Saskatoon, Saskatchewan, S7K 3H3

  • Boehringer Ingelheim Investigational Site

    Saskatoon, Saskatchewan, S7K 7H9

  • c/o Hemodynamics Offices

    Saskatoon, Saskatchewan, S7N 0W8

  • LMC Thornhill

    Thornhill, Ontario, L4J 1V8

  • Boehringer Ingelheim Investigational Site

    Thunder Bay, Ontario, P7E 6E7

  • Boehringer Ingelheim Investigational Site

    Toronto, Ontario, M4R 2G4

  • Dr. Hugh Tildesley

    Vancouver, British Columbia, V6E 1M7

  • Boehringer Ingelheim Investigational Site

    Vancouver, British Columbia, V6Z 1Y8

Other trials in Canada

Mexico5 sites

  • Boehringer Ingelheim Investigational Site

    Col. Magdalena de Las Salinas, C.P 07300

  • Boehringer Ingelheim Investigational Site

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

  • Boehringer Ingelheim Investigational Site

    Colonia del Valle, CP 03100

  • Boehringer Ingelheim Investigational Site

    Guadalajara, Jalisco, C.P 44700

  • Boehringer Ingelheim Investigational Site

    Zapopan, Jalisco, 45100

Other trials in Mexico

Argentina3 sites

  • Boehringer Ingelheim Investigational Site

    BsAs, C1425AST

  • Boehringer Ingelheim Investigational Site

    Coronel Suárez, 7540

  • Boehringer Ingelheim Investigational Site

    Rosario, Santa Fe, 2000

Other trials in Argentina

Australia3 sites

  • Boehringer Ingelheim Investigational Site

    Kippa-Ring, Queensland, 4021

  • Emeritus Research

    Malvern, Victoria, 3144

  • Boehringer Ingelheim Investigational Site

    Prahran, Victoria, 3181

Other trials in Australia

South Korea3 sites

  • Inje University Pusan Hospital

    Busan

  • Yeungnam University Medical Center

    Daegu, 705717

  • Korea University Medical Center

    Seoul, 136705

Other trials in South Korea

New Zealand2 sites

  • Boehringer Ingelheim Investigational Site

    Auckland

  • 1st Floor Hagely Hostel

    Christchurch

Other trials in New Zealand

Taiwan1 site

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

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.

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

Read the 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:

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)

Being tested
telmisartan combined with hydrochlorothiazide (80/12.5 mg), valsartan combined with hydrochlorothiazide (160/12.5mg)
Medical subject headings
Hypertension, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telmisartan combined with hydrochlorothiazide (80/12.5 mg)Drug

  • valsartan combined with hydrochlorothiazide (160/12.5mg)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 10 weeks

Secondary outcomes (8)

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

    Measured: 10 weeks

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

    Measured: 10 weeks

  3. 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.

    Measured: 10 weeks

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

    Measured: 10 weeks

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

    Measured: 10 weeks

  6. 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.

    Measured: 4 weeks and 10 weeks

  7. Responder rates based on the mean seated trough cuff measurements

    Measured: 4 weeks and 10 weeks

  8. Metabolic and inflammatory marker changes from baseline

    Measured: up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2005 (estimated)
  2. Study startJan 2003
  3. Primary completionDec 2004
  4. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
840 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00239538
Sponsor's protocol ID
502.399
Status last verified
Nov 2013
First submitted
14 Oct 2005
Last updated
8 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing telmisartan combined with hydrochlorothiazide (80/12.5 mg) and valsartan combined with hydrochlorothiazide (160/12.5mg) in people with Hypertension and Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 102 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Canada, Mexico, Argentina, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00239538.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.

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