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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316095
• Other study ID #: 1228.1
• Secondary ID: EudraCT No.: 200
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2006
• Last updated: October 31, 2013
• Start date: April 2006
• Est. completion date: August 2007

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Commissie Mensgebonden Onderzoek (CCMO)Austria: Ministry of Healthcare and Social Development of Russian Federation, MoscowAustria: Ministry of Health Crae of Ukraine (MoH of Ukraine)France: Agence Francaise de Securite Sanitaire des Produits de SanteSweden: Medical Products AgencySouth Africa: Medicines Control Council (MCC)Taiwan: Department of Health, Executive Yuan, ROCHong Kong: Department of Health Pharmaceuticals Registration and Import / Export Central SectionGermany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)China: Food and Drug AdministrationKorea, Republic of: Korea Food and Drug AdministrationAustria: SUKL (state institute for drug control)Austria: State Institute for Drug Control (SUKL)
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1695
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. Group I Hypertension and Hypercholesterolemia only

2. Group II Hypertension and Hypercholesterolemia plus > 1 risk factors

3. 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

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• telmisartan

• simvastatin

Locations

Country	Name	City	State
Czech Republic	Boehringer Ingelheim Investigational Site	Benatky nad Jizerou
Czech Republic	Boehringer Ingelheim Investigational Site	Brno
Czech Republic	Boehringer Ingelheim Investigational Site	Mlada Boleslav
Czech Republic	Boehringer Ingelheim Investigational Site	Plzen
Czech Republic	Boehringer Ingelheim Investigational Site	Praha 5
Czech Republic	Boehringer Ingelheim Investigational Site	Pribram
Czech Republic	Boehringer Ingelheim Investigational Site	Unicov
Czech Republic	Boehringer Ingelheim Investigational Site	Usti nad Orlici
France	ALTI	Angers
France	Boehringer Ingelheim Investigational Site	Angers
France	Boehringer Ingelheim Investigational Site	Sidi Daoud Tunis
France	Boehringer Ingelheim Investigational Site	Tunis
Germany	Boehringer Ingelheim Investigational Site	Haag
Germany	Boehringer Ingelheim Investigational Site	Mainz
Germany	Boehringer Ingelheim Investigational Site	Neuburg a. d. Donau
Germany	Boehringer Ingelheim Investigational Site	Nurnberg
Germany	Boehringer Ingelheim Investigational Site	Rednitzhembach
Germany	Boehringer Ingelheim Investigational Site	Unterschneidheim
Germany	Boehringer Ingelheim Investigational Site	Westerkappeln
Germany	Boehringer Ingelheim Investigational Site	Wiesbaden
Germany	Boehringer Ingelheim Investigational Site	Wurzburg
Hong Kong	Boehringer Ingelheim Investigational Site	Hong Kong
Korea, Republic of	Chonnam National University Hospital	Kwangju
Korea, Republic of	Hallym University Sacred Heart Hospital	Kyunggi-do
Korea, Republic of	Korea University Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	St. Mary Hospital	Seoul
Netherlands	Boehringer Ingelheim Investigational Site	Almere
Netherlands	Boehringer Ingelheim Investigational Site	Beek en Donk
Netherlands	Andromed Breda	Breda
Netherlands	Gemini Ziekenhuis	Den Helder
Netherlands	Andromed Eindhoven	Eindhoven
Netherlands	Boehringer Ingelheim Investigational Site	Ewijk
Netherlands	Andromed Noord	Groningen
Netherlands	Andromed Leiden	Leiden
Netherlands	Andromed Nijmegen	Nijmegen
Netherlands	Boehringer Ingelheim Investigational Site	Oude Pekela
Netherlands	Andromed Rotterdam	Rotterdam
Netherlands	Julius Center for Patient oriented Research	Utrecht
Netherlands	Andromed Oost	Velp
Netherlands	Boehringer Ingelheim Investigational Site	Wildervank
Netherlands	Andromed Zoetermeer	Zoetermeer
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	Boehringer Ingelheim Investigational Site	St. Petersburg
Slovakia	Boehringer Ingelheim Investigational Site	Bratislava
Slovakia	Boehringer Ingelheim Investigational Site	Kosice
Slovakia	Boehringer Ingelheim Investigational Site	Kralovsky Chmlec
Slovakia	Boehringer Ingelheim Investigational Site	Liptovsky Hradok
Slovakia	Boehringer Ingelheim Investigational Site	Nitra
Slovakia	Boehringer Ingelheim Investigational Site	Povazska Bystrica
Slovakia	Boehringer Ingelheim Investigational Site	Presov
Slovakia	Boehringer Ingelheim Investigational Site	Trencin
Slovakia	Boehringer Ingelheim Investigational Site	Vrable
South Africa	Boehringer Ingelheim Investigational Site	Boksburg
South Africa	Boehringer Ingelheim Investigational Site	Cape Town
South Africa	Boehringer Ingelheim Investigational Site	Cape Town
South Africa	Boehringer Ingelheim Investigational Site	Durban
South Africa	Boehringer Ingelheim Investigational Site	Johannesburg
South Africa	Boehringer Ingelheim Investigational Site	Krugersdorp
South Africa	Boehringer Ingelheim Investigational Site	Midrand
Sweden	Medicinkliniken	Goteborg
Sweden	Boehringer Ingelheim Investigational Site	Lule?
Sweden	Medicinkliniken	Lule?
Sweden	Endokrinologkliniken	Malmo
Sweden	Boehringer Ingelheim Investigational Site	Rattvik
Sweden	Medicinkliniken	Stockholm
Sweden	Boehringer Ingelheim Investigational Site	Uppsala
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital	Taoyuan
Ukraine	Boehringer Ingelheim Investigational Site	Dnepropetrovsk
Ukraine	Boehringer Ingelheim Investigational Site	Dnepropetrovsk
Ukraine	Boehringer Ingelheim Investigational Site	Ivano-Frankovsk
Ukraine	Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	Boehringer Ingelheim Investigational Site	Kiev
Ukraine	Boehringer Ingelheim Investigational Site	Kiev
Ukraine	Boehringer Ingelheim Investigational Site	Kiev
Ukraine	Boehringer Ingelheim Investigational Site	Kiev
Ukraine	Boehringer Ingelheim Investigational Site	Lutsk
Ukraine	Boehringer Ingelheim Investigational Site	Lvov
Ukraine	Boehringer Ingelheim Investigational Site	Lvov
Ukraine	Boehringer Ingelheim Investigational Site	Zaporozhye

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Czech Republic,  France,  Germany,  Hong Kong,  Korea, Republic of,  Netherlands,  Russian Federation,  Slovakia,  South Africa,  Sweden,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean diastolic blood pressure (DBP)		8 weeks	No
Primary	Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean low density lipoprotein (LDL)		8 weeks	No
Secondary	Change in the 24-hour ABPM (Ambulatory Blood Pressure Monitoring) measured mean SBP		after 8 weeks	No
Secondary	Changes in Trough-to-peak ratios of SBP and DBP, taken from ABPM		after 8 weeks	No
Secondary	Changes in Seated morning DBP and SBP		after 8 weeks	No
Secondary	Response rate to blood pressure treatment		after 8 weeks	No
Secondary	Response rate to lipid lowering treatment		after 8 weeks	No
Secondary	Change in Total cholesterol		after 8 weeks	No
Secondary	Change in HDL-cholesterol		after 8 weeks	No
Secondary	Change in triglycerides		after 8 weeks	No
Secondary	Change in Apolipoprotein B		after 8 weeks	No
Secondary	Change in free fatty acids		after 8 weeks	No
Secondary	Change in Adiponectin		after 8 weeks	No
Secondary	Change in HOMA-index		after 8 weeks	No
Secondary	Change in haemoglobin A1C		after 8 weeks	No
Secondary	Changes in high sensitive c-reactive protein		after 8 weeks	No
Secondary	Changes in microalbuminuria		after 8 weeks	No
Secondary	Adverse events		up to 15 weeks	No
Secondary	Changes in clinical laboratory parameter		up to 15 weeks	No
Secondary	Assessment of pulse rate		up to 15 weeks	No