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HypertensionPhase 3NCT00316095

Combination of Telmisartan and Simvastatin in the Treatment of Hypertension and Hypercholesterolemia

A Phase 3 study testing telmisartan and simvastatin in people with Hypertension and Dyslipidemias, run by Boehringer Ingelheim at 92 sites in 12 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

This study will investigate two registered drugs, one for the treatment of high blood pressure and one for the treatment of elevated cholesterol. High blood pressure (hypertension) is a common medical condition affecting millions of people worldwide. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Dyslipidemias
What is being tested?
telmisartan and simvastatin
How many people
1,695 participants
Where
92 sitesin 12 countries
Study dates
Apr 2006to Aug 2007
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent
  • Age 18 years or older
  • Hypertension as defined by a mean seated cuff DBP of >=95 - 109 mmHg
  • Hypercholesterolemia as defined by a fasting LDL-C level at visit 2 according to
  • CV risk shown in table below:
  • CV Risk Group:
Show all 12Show fewer
  • Group I Hypertension and Hypercholesterolemia only
  • Group II Hypertension and Hypercholesterolemia plus > 1 risk factors
  • Group III Hypertension and Hypercholesterolemia plus CHD and/or diabetes mellitus and/or other athero-sclerotic disease
  • Fasting LDL-C group I and II: 100-250 mg/dL (2.6-6.5 mmol/L)
  • Fasting LDL-C group III: 100-160 mg/dL (2.6-4.1 mmol/L)
  • Risk factors: >= 45 yrs if male, >= 55 years if female, family history of CHD, current smoker, HDL-C < 40 mg/dL

Who cannot join

  • pre-menopausal women who are not surgically sterile or are nursing or pregnant or are of child-bearing potential and are not practicing acceptable means of birth control
  • inability to stop current antihypertensive and/or cholesterol-lowering therapies
  • contraindication to a washout/placebo treatment
  • clinically relevant cardiac arrhythmias
  • hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
  • mean sitting SBP >=180 mmHg or mean sitting DBP >=110 mmHg at two consecutive visits
Show all 22Show fewer
  • known or suspected secondary hypertension
  • known or suspected secondary hyperlipidemia of any etiology
  • diabetes that has not been stable and controlled for the previous three months
  • severe renal dysfunction
  • bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or one kidney
  • biliary obstructive disorders, hepatic insufficiency, including past or current liver disease
  • clinically relevant hypokalaemia or hyperkalaemia
  • uncorrected volume depletion
  • uncorrected sodium depletion
  • any history of myopathy or rhabdomyolysis during the past treatment with HMG Co-A reductase inhibitors
  • concurrent use of large quantities of grapefruit juice
  • known hypersensitivity or intolerance to HMG Co-A reductase inhibitors and/or angiotensin receptor blockers, hereditary fructose intolerance
  • planned significant diet and/or lifestyle (including exercise) changes during the treatment phase of the trial
  • history of drug or alcohol dependency
  • any investigational drug therapy within one month of providing informed consent
  • any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medications

Trial locations and contacts

92 sites in 12 countries.

92 sites in 12 countries

Netherlands15 sites

  • Boehringer Ingelheim Investigational Site

    Almere Stad, 1311RL

  • Boehringer Ingelheim Investigational Site

    Beek en Donk, 5741 CG

  • Andromed Breda

    Breda, 4811 VL

  • Gemini Ziekenhuis

    Den Helder, 1782 GZ

  • Andromed Eindhoven

    Eindhoven, 5611 NJ

  • Boehringer Ingelheim Investigational Site

    Ewijk, 6644 CL

  • Andromed Noord

    Groningen, 9711 SG

  • Andromed Leiden

    Leiden, 2311 GZ

  • Andromed Nijmegen

    Nijmegen, 6533 HL

  • Boehringer Ingelheim Investigational Site

    Oude Pekela, 9665 BJ

  • Andromed Rotterdam

    Rotterdam, 3021 HC

  • Julius Center for Patient oriented Research

    Utrecht, 3584 CJ

  • Andromed Oost

    Velp, 6883 ES

  • Boehringer Ingelheim Investigational Site

    Wildervank, 9648 BE

  • Andromed Zoetermeer

    Zoetermeer, 2724 EK

Other trials in Netherlands

Ukraine13 sites

  • Boehringer Ingelheim Investigational Site

    Dnipro, 49006

  • Boehringer Ingelheim Investigational Site

    Dnipro, 49023

  • Boehringer Ingelheim Investigational Site

    Ivano-Frankivsk, 76000

  • Boehringer Ingelheim Investigational Site

    Kharkiv, 61018

  • Boehringer Ingelheim Investigational Site

    Kharkiv, 61037

  • Boehringer Ingelheim Investigational Site

    Kiev, 02175

  • Boehringer Ingelheim Investigational Site

    Kiev, 03151

  • Boehringer Ingelheim Investigational Site

    Kiev, 03680

  • Boehringer Ingelheim Investigational Site

    Kiev, 04114

  • Boehringer Ingelheim Investigational Site

    Lutsk, 43024

  • Boehringer Ingelheim Investigational Site

    Lviv, 73013

  • Boehringer Ingelheim Investigational Site

    Lviv, 79015

  • Boehringer Ingelheim Investigational Site

    Zaporizhzhya, 69035

Other trials in Ukraine

Russia10 sites

  • Boehringer Ingelheim Investigational Site

    Moscow, 101990

  • Boehringer Ingelheim Investigational Site

    Moscow, 117036

  • Boehringer Ingelheim Investigational Site

    Moscow, 119992

  • Boehringer Ingelheim Investigational Site

    Moscow, 121356

  • Boehringer Ingelheim Investigational Site

    Moscow, 121552

  • Boehringer Ingelheim Investigational Site

    Moscow, 127018

  • Boehringer Ingelheim Investigational Site

    Moscow, 129010

  • Boehringer Ingelheim Investigational Site

    Moscow

  • Boehringer Ingelheim Investigational Site

    Saint Petersburg, 195257

  • Boehringer Ingelheim Investigational Site

    Saint Petersburg, 198013

Other trials in Russia

Germany9 sites

  • Boehringer Ingelheim Investigational Site

    Haag, 83527

  • Boehringer Ingelheim Investigational Site

    Mainz, 55116

  • Boehringer Ingelheim Investigational Site

    Neuburg A. D. Donau, 86633

  • Boehringer Ingelheim Investigational Site

    Nuremberg, 90402

  • Boehringer Ingelheim Investigational Site

    Rednitzhembach, 91126

  • Boehringer Ingelheim Investigational Site

    Unterschneidheim, 73485

  • Boehringer Ingelheim Investigational Site

    Westerkappeln, 49492

  • Boehringer Ingelheim Investigational Site

    Wiesbaden, 65191

  • Boehringer Ingelheim Investigational Site

    Würzburg, 97072

Other trials in Germany

Slovakia9 sites

  • Boehringer Ingelheim Investigational Site

    Bratislava, 82606

  • Boehringer Ingelheim Investigational Site

    Košice, 040 01

  • Boehringer Ingelheim Investigational Site

    Kralovsky Chmlec, 077 01

  • Boehringer Ingelheim Investigational Site

    Liptovský Hrádok, 033 01

  • Boehringer Ingelheim Investigational Site

    Nitra, 950 01

  • Boehringer Ingelheim Investigational Site

    Považská Bystrica, 017 01

  • Boehringer Ingelheim Investigational Site

    Prešov, 081 81

  • Boehringer Ingelheim Investigational Site

    Trenčín, 911 05

  • Boehringer Ingelheim Investigational Site

    Vráble, 952 01

Other trials in Slovakia

Czechia8 sites

  • Boehringer Ingelheim Investigational Site

    Benátky nad Jizerou, 294 71

  • Boehringer Ingelheim Investigational Site

    Brno, 65691

  • Boehringer Ingelheim Investigational Site

    Mladá Boleslav, 293 01

  • Boehringer Ingelheim Investigational Site

    Pilsen, 301 00

  • Boehringer Ingelheim Investigational Site

    Prague, 158 00

  • Boehringer Ingelheim Investigational Site

    Příbram, 261 01

  • Boehringer Ingelheim Investigational Site

    Uničov, 783 91

  • Boehringer Ingelheim Investigational Site

    Ústí nad Orlicí, 562 18

Other trials in Czechia

South Africa7 sites

  • Boehringer Ingelheim Investigational Site

    Boksburg, 1461

  • Boehringer Ingelheim Investigational Site

    Cape Town, 7405

  • Boehringer Ingelheim Investigational Site

    Cape Town, 7925

  • Boehringer Ingelheim Investigational Site

    Durban, 4091

  • Boehringer Ingelheim Investigational Site

    Johannesburg, 2033

  • Boehringer Ingelheim Investigational Site

    Krugersdorp, 1739

  • Boehringer Ingelheim Investigational Site

    Midrand, 1685

Other trials in South Africa

Sweden7 sites

  • Medicinkliniken

    Gothenburg, 416 85

  • Medicinkliniken

    Lule?, 971 80

  • Boehringer Ingelheim Investigational Site

    Lule?, S-971 31

  • Endokrinologkliniken

    Malmö, 205 02

  • Boehringer Ingelheim Investigational Site

    Rättvik, 795 33

  • Medicinkliniken

    Stockholm, 182 88

  • Boehringer Ingelheim Investigational Site

    Uppsala, S-752 23

Other trials in Sweden

South Korea6 sites

  • Chonnam National University Hospital

    Kwangju, 501757

  • Hallym University Sacred Heart Hospital

    Kyunggi-do, 431070

  • Seoul National University Hospital

    Seoul, 110774

  • Severance Hospital

    Seoul, 120752

  • Korea University Medical Center

    Seoul, 136705

  • St. Mary Hospital

    Seoul, 150713

Other trials in South Korea

France4 sites

  • ALTI

    Angers, 49000

  • Boehringer Ingelheim Investigational Site

    Angers, 49000

  • Boehringer Ingelheim Investigational Site

    Sidi Daoud Tunis, 2046

  • Boehringer Ingelheim Investigational Site

    Tunis, 1089

Other trials in France

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan, 704

  • Mackay Memorial Hospital

    Taipei, 104

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Hong Kong1 site

  • Boehringer Ingelheim Investigational Site

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Reduced Factorial Design, Randomized, Double Blind Trial Comparing Combinations of Telmisartan 20 or 80 mg and Simvastatin 20 or 40 mg With Single Component Therapies in the Treatment of Hypertension and Dyslipidemia

This study will investigate two registered drugs, one for the treatment of high blood pressure and one for the treatment of elevated cholesterol. High blood pressure (hypertension) is a common medical condition affecting millions of people worldwide. A wide variety of effective drug treatments is available to reduce blood pressure. Elevated cholesterol (hypercholesterolemia) is a common medical condition affecting people worldwide. A wide variety of effective drug treatments is available to reduce cholesterol levels.

Hypertension and hypercholesterolemia often occur together. They are both important risk factors for the development of heart and vessel diseases (e.g. heart attack or stroke). Current guidelines advise treatment of high blood pressure and elevated cholesterol to reduce the risk of cardiovascular diseases. This study will test the simultaneous use of a drug to reduce blood pressure and a drug to reduce elevated cholesterol. Both drugs are registered and are effective. The drug for treatment of high blood pressure is telmisartan Micardis). The drug for treatment of elevated cholesterol is simvastatin (Zocor). Since hypertension and hypercholesterolemia frequently occur together, the purpose of this study is to investigate whether both drugs can be used simultaneously. A low dose and a high dose of these drugs will be used. It will be investigated whether each of the drugs is still as effective when given together, at the same time of day, with the other drug.

Being tested
telmisartan, simvastatin
Medical subject headings
Hypertension, Dyslipidemias

What participants receive

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

What is being measured

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

  1. Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean diastolic blood pressure (DBP)

    Measured: 8 weeks

  2. Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean low density lipoprotein (LDL)

    Measured: 8 weeks

Secondary outcomes (18)

  1. Change in the 24-hour ABPM (Ambulatory Blood Pressure Monitoring) measured mean SBP

    Measured: after 8 weeks

  2. Changes in Trough-to-peak ratios of SBP and DBP, taken from ABPM

    Measured: after 8 weeks

  3. Changes in Seated morning DBP and SBP

    Measured: after 8 weeks

  4. Response rate to blood pressure treatment

    Measured: after 8 weeks

  5. Response rate to lipid lowering treatment

    Measured: after 8 weeks

  6. Change in Total cholesterol

    Measured: after 8 weeks

  7. Change in HDL-cholesterol

    Measured: after 8 weeks

  8. Change in triglycerides

    Measured: after 8 weeks

  9. Change in Apolipoprotein B

    Measured: after 8 weeks

  10. Change in free fatty acids

    Measured: after 8 weeks

  11. Change in Adiponectin

    Measured: after 8 weeks

  12. Change in HOMA-index

    Measured: after 8 weeks

  13. Change in haemoglobin A1C

    Measured: after 8 weeks

  14. Changes in high sensitive c-reactive protein

    Measured: after 8 weeks

  15. Changes in microalbuminuria

    Measured: after 8 weeks

  16. Adverse events

    Measured: up to 15 weeks

  17. Changes in clinical laboratory parameter

    Measured: up to 15 weeks

  18. Assessment of pulse rate

    Measured: up to 15 weeks

Timeline

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

  1. First posted20 Apr 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionAug 2007
  4. Study completionAug 2007

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
1,695 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00316095
Sponsor's protocol ID
1228.1
Other IDs
EudraCT No.: 2005-002851-41
Status last verified
Oct 2013
First submitted
19 Apr 2006
Last updated
1 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing telmisartan and simvastatin in people with Hypertension and Dyslipidemias, run by Boehringer Ingelheim at 92 sites in 12 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 12 inclusion and 22 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 1 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 92 sites in Netherlands, Ukraine, Russia, Germany, Slovakia and 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean diastolic blood pressure (DBP) (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT00316095.

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 1 Nov 2013.

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