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HypertensionPhase 4NCT00750113

Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.

A Phase 4 study testing Nifidipine, Telmisartan and Nifedipine/Telmisartan in people with Hypertension, run by Bayer at 43 sites in 2 countries.

Completed

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

Official record
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Trial summary

Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing cardiovascular events such as myocardial infarction or stroke. To reduce this risk an appropriate antihypertensive therapy should allow to reach a target blood pressure of less than 130/80 mmHg in order to maximise… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertension
What is being tested?
Nifidipine, Telmisartan and Nifedipine/Telmisartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
405 participants
Where
43 sitesin 2 countries
Study dates
Oct 2007to Aug 2009
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hypertension (office systolic blood pressure > 135 mmHg), untreated or poorly controlled but stable antihypertensive regimen for >/= 4 weeks
  • Presence of type 2 diabetes mellitus or target organ damage (echocardiographic or electrocardiographic left ventricular hypertrophy or microalbuminuria)
  • Presence of a metabolic syndrome, i.e at least two of the following [(from letter (a) to letter(d)] in patients with organ damage or at least one of the following [from letter (b) to letter (d)] in patients with diabetes mellitus: (a) impaired glucose tolerance (fasting plasma glucose 110 -125 mg/dl) (b )raised serum triglycerides (>/= 150 mg/dl) or comitant use of statins for this indication(c) low HDL cholesterol (males: < 40 mg/dl, females: < 50 mg/dl)(d) waist circumference >102 cm in men and >88 cm in women
  • Age: 18-75 years
  • Negative pregnancy test in females
  • Written informed consent

Who cannot join

  • Concomitant treatment with AT1-antagonists e.g. losartan, eprosartan, telmisartan) or calcium-antagonists (e.g. amlodipine, felodipine, isradipine, nifedipine, nimodipine).
  • Concomitant treatment with any other antihypertensive medication that cannot be safely withdrawn at entry (i.e taken on a stable regimen for >/= 4 week) and that won't possibly be kept stable over the whole duration of the study.
  • Concomitant treatment with known cytochrome P450-3A4 inhibitors (e.g cimetidine, anti-HIV protease inhibitors e.g. ritonavir, azole anti-mycotics eg. Ketoconazole, digoxin, quinidine, tacrolimus) or inducers such as anti-epileptic drugs (eg. phenytoin, carbamazepine and phenobarbitone) or rifampicin
  • Concomitant treatment with potassium sparingdiuretics.
  • Malignant, severe or labile essential hypertension, orthostatic hypotension
  • Cardiovascular shock
Show all 21Show fewer
  • Evidence of secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis or pheochromocytoma
  • Myocardial infarction or unstable angina within the previous 12 months
  • Severe cardiac valve disease
  • Severe rhythm or conduction disorder:
  • Cerebrovascular ischaemic event (stroke, transient ischaemic attack) within the previous 12 months
  • History of intra-cerebral haemorrhage or sub-arachnoid haemorrhage within the previous 12 months
  • Type 1 diabetes mellitus
  • Proteinuria (determined by uristix)
  • BMI > 34
  • Uncorrected hypokalemia or hyperkalemia, potassium outside the range 3.0 to 5.5 mmol/l
  • Sodium depletion and/or hypovolemia
  • Gastrointestinal disease resulting in the potential for malabsorption)
  • Liver disease or transaminase (AST, ALT) levels > 3 x the upper limit of normal range.
  • Renal failure, creatinine >2.0 mg/dl
  • General Exclusion Criteria: any malignant disease that has required treatment within the last five years, dementia or psychosis, history of non-compliance, alcoholism or drug abuse, treatment with any other investigational drug in the 30 days prior to entering the study, pregnancy and lactation, known state of allergy or hypersensitivity to nifedipine or any other dihydropyridine or to telmisartan, any surgical or medical condition which at the discretion of the investigator place the subject at higher risk from his/her participation in the study or are likely to prevent the subject from complying with the requirements of the study or completing the trial period, history of non compliance to medical regimens or subjects unwilling to comply with the study protocol.

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

Italy31 sites

  • Study site

    Ancona, 60126

  • Study site

    Bologna, 40138

  • Study site

    Brescia, 25123

  • Study site

    Broni, 27043

  • Study site

    Catania, 95126

  • Study site

    Cinisello Balsamo, 20092

  • Study site

    Ferrara, 44100

  • Study site

    L’Aquila, 67100

  • Study site

    Milan, 20143

  • Study site

    Monza, Monza-Brianza, 20052

  • Study site

    Naples, 80136

  • Study site

    Naples, 80141

  • Study site

    Novara, 28100

  • Study site

    Padova, 35128

  • Study site

    Palermo, 90127

  • Study site

    Pavia, 27100

  • Study site

    Perugia, 06129

  • Study site

    Pisa, 56126

  • Study site

    Pozzilli, Isernia, 86077

  • Study site

    Reggio Emilia, 42100

  • Study site

    Roma, 00152

  • Study site

    Roma, 00157

  • Study site

    Roma, 00161

  • Study site

    Sassari, 07100

  • Study site

    Siena, 53100

  • Study site

    Somma Lombardo, Varese, 21013

  • Study site

    Syracuse, 96100

  • Study site

    Treviso, 31100

  • Study site

    Trieste, 34149

  • Study site

    Varese, 21100

  • Study site

    Venezia, 30122

Other trials in Italy

Spain12 sites

  • Study site

    Badajoz, Badajoz, 06080

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Benigànim, Valencia, 46830

  • Study site

    Ciudad Real, Ciudad Real, 13005

  • Study site

    Ferrol, A Coruña, 15405

  • Study site

    Gijón, Principality of Asturias, 33394

  • Study site

    Jerez de la Frontera, Cádiz, 11407

  • Study site

    Las Palmas de Gran Canaria, Las Palmas, 35020

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Málaga, Málaga, 29010

  • Study site

    Valencia, Valencia, 46006

Other trials in Spain

About this study

Official title: A Multicenter Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control and Beyond: Comparison of Two Treatment Strategies.

Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing cardiovascular events such as myocardial infarction or stroke. To reduce this risk an appropriate antihypertensive therapy should allow to reach a target blood pressure of less than 130/80 mmHg in order to maximise cardiovascular protection.The purpose of this study is to evaluate the efficacy in blood pressure control when anti-hypertensive therapy is initiated with a combination of low dose Nifedipine GITS and Telmisartan compared to a regimen starting with monotherapy before adding the other drug.The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM) at 16 weeks of treatment compared to baseline

Conditions
Hypertension
Being tested
Nifidipine, Telmisartan, Nifedipine/Telmisartan
Medical subject headings
Hypertension

What participants receive

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

  • NifidipineDrug

    Tablets 20 Mg daily for 4 weeks then combination therapy

  • TelmisartanDrug

    Tablets 80 Mg daily for 4 weeks then combination therapy

  • Nifedipine/TelmisartanDrug

    2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning

Study groups in NCT00750113
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Nifidipine
Arm 2ExperimentalNot described
Receives: Drug: Telmisartan
Arm 3ExperimentalNot described
Receives: Drug: Nifedipine/Telmisartan

What is being measured

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

  1. The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM)

    Measured: at 16 weeks of treatment compared to baseline

Secondary outcomes (5)

  1. Office blood pressure, response rate (> 10mmHg decrease control rate (< 130/80) mean SBP, mean DBP.

    Measured: 8, 16 weeks of treatment

  2. ABPM: % patients achieving BP < 125/80 mmHg morning BP increase/surge,24h mean diastolic BP,day average BP, night average BP,BP variability, pulse pressure through to peak ratio,smoothness index dipping or non dipping

    Measured: 8, 16 and 24 weeks

  3. Microalbuminuria in subgroup (any reduction)

    Measured: 8, 16 and 24 weeks

  4. Metabolic parameters: fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides

    Measured: 8, 16 and 24 weeks

  5. Inflammatory markers: sRAGE (soluble receptors for advanced glycation end products) eotaxin-3, CRP (C-Reactive Protein)

    Measured: 8, 16 and 24 weeks

Timeline

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

  1. First posted10 Sep 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionJul 2009
  4. Study completionAug 2009

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
Double blind
Who is masked
Participant, Investigator
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00750113
Sponsor's protocol ID
12313
Other IDs
2006-006436-22
Status last verified
Dec 2014
First submitted
9 Sep 2008
Last updated
5 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Mancia G, Parati G, Bilo G, Choi J, Kilama MO, Ruilope LM; TALENT investigators. Blood pressure control by the nifedipine GITS-telmisartan combination in patients at high cardiovascular risk: the TALENT study. J Hypertens. 2011 Mar;29(3):600-9. doi: 10.1097/HJH.0b013e328342ef04.

    PubMed 21252701

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nifidipine, Telmisartan and Nifedipine/Telmisartan in people with Hypertension, run by Bayer at 43 sites in 2 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 6 inclusion and 21 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Italy, Spain. 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?

The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM) (time frame: at 16 weeks of treatment compared to baseline). 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 NCT00750113, which also lists 1 linked publication.

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 5 Dec 2014.

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