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HypertensionPhase 3NCT00441350

Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension

A Phase 3 study testing OM 40 and OM/HCTZ 40/12.5 in people with Hypertension, run by Menarini Group at 65 sites in 8 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

The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ 40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic BP in hypertensive patients after 8 weeks of double-blind treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
OM 40 and OM/HCTZ 40/12.5
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,004 participants
Where
65 sitesin 8 countries
Study dates
Jul 2007to May 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients with a diagnosis of essential hypertension, either treatment-naive or including currently on anti-hypertensive medication (in Italy only treatment naive patients) in whom it is medically justifiable to withdraw treatment , and who are likely to meet the required BP inclusion criteria at randomisation:
  • Mean sitting dBP ≥ 100 mmHg and ≤ 120 mmHg.
  • Mean sitting sBP ≥ 160 mmHg and ≤ 200 mmHg.
  • Main Exclusion Criteria:
  • Mean sitting sBP values > 200 mmHg and/or dBP > 120 mmHg.
  • Pregnant or nursing women.
  • Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the tested medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological, oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients.
  • Patients with secondary hypertension of any aetiology such as renal disease, pheochromocytoma, or Cushing's syndrome.

Who cannot join

None listed.

Trial locations and contacts

65 sites in 8 countries.

65 sites in 8 countries

Germany16 sites

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Dresden

  • Study site

    Einbeck

  • Study site

    Essen

  • Study site

    Giengen an der Brenz

  • Study site

    Großheirath

  • Study site

    Hamburg

  • Study site

    Hanau

  • Study site

    Heidelberg

  • Study site

    Künzing

  • Study site

    Leipzig

  • Study site

    Lollar

  • Study site

    Mannheim

  • Study site

    München

  • Study site

    Nuremberg

Other trials in Germany

Czechia10 sites

  • Study site

    Benátky nad Jizerou

  • Study site

    Bílovec

  • Study site

    Brodce

  • Study site

    Jablonec nad Nisou

  • Study site

    Mladá Boleslav

  • Study site

    Prague

  • Study site

    Rokycany

  • Study site

    Tábor

  • Study site

    Teplice

  • Study site

    Uničov

Other trials in Czechia

Israel9 sites

  • Study site

    Ashkelon

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Nahariya

  • Study site

    Petah Tikva

  • Study site

    Tel Aviv

  • Study site

    Tel HaShomer

Other trials in Israel

Italy8 sites

  • Study site

    Busto Arsizio

  • Study site

    Ferrara

  • Study site

    Pavia

  • Study site

    Pisa

  • Study site

    San Daniele del Friuli

  • Study site

    Sassari

  • Study site

    Somma Lombardo

  • Study site

    Venezia

Other trials in Italy

Poland7 sites

  • Study site

    Bialystok

  • Study site

    Gdansk

  • Study site

    Gdynia

  • Study site

    Lublin

  • Study site

    Płock

  • Study site

    Wąbrzeżno

  • Study site

    Warsaw

Other trials in Poland

Croatia6 sites

  • Study site

    Rijeka

  • Study site

    Slavonski Brod

  • Study site

    Split

  • Study site

    Varaždin

  • Study site

    Zadar

  • Study site

    Zagreb

Other trials in Croatia

Romania6 sites

  • Study site

    Baia Mare

  • Study site

    Brăila

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Oradea

  • Study site

    Suceava

Other trials in Romania

Denmark3 sites

  • Study site

    Aalborg

  • Study site

    Ballerup Municipality

  • Study site

    Vejle

Other trials in Denmark

About this study

Official title: Phase III Study Evaluating the Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Patients With Essential Hypertension

The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ 40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic BP in hypertensive patients after 8 weeks of double-blind treatment.

The study consisted of two sequential phases of 8 weeks duration each:

Read more

During the first phase, OM 40 mg monotherapy was compared with OM/HCTZ 40/12.5 mg in order to evaluate the additional benefit of OM/HCTZ 40/12.5 mg in the treatment of essential moderate to severe hypertension.

During the second phase, patients whose BP proved to be insufficiently controlled by the OM 40 mg monotherapy were to start OM/HCTZ 40/12.5 mg combination therapy while patients whose BP proved to be insufficiently controlled by the OM/HCTZ 40/12.5 mg combination were to be up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the up-titrated combination.

The study was be conducted by qualified and experienced personnel with adherence to GCP, current guidelines on the design of studies in hypertension, the applicable regulatory requirements and the ethical principles based on the Declaration of Helsinki.

Read the detailed description

Methodology:

After the signature of the informed consent, patients were screened for eligibility and eligible patients entered into a pre-randomisation period consisting of a taper-off phase of approximately 1-2 weeks (during which patients treated for hypertension were to discontinue their antihypertensive therapy) followed by a 2-week single-blind placebo run-in phase (Visit 1). After conclusion of the placebo run-in phase (Visit 2), eligible patients were randomised to the double-blind active treatment period which consisted of two phases:

First double-blind treatment phase (Phase A, from Randomisation to Week 8):

Eligible patients with mean sitting sBP ≥ 160 and ≤ 200 mmHg and dBP ≥ 100 mmHg and ≤ 120 mmHg were randomised in a 1:2 ratio to receive either OM 40 mg or OM/HCTZ 40/12.5 mg for a total of 8 weeks of treatment (Phase A). Study visits were held after 4 and 8 weeks of double-blind active treatment (Visit 3 and 4, respectively). After 8 weeks (Visit 4), patients reaching the BP goal of < 140/90 mmHg or < 130/80 mmHg for diabetics were considered as responders. All patients (responders and non-responders) then entered into the titration phase of the study (Phase B):

Second double-blind treatment phase/titration phase (Phase B, from Week 8 to Week 16):

Treatment assignment in the second part of the study was based on the following criteria:

  • Responders to Phase A treatment continued to receive the same double-blind treatment for an additional 8 weeks.
  • Non-responders Phase A treatment had their treatment assigned as follows:
  • Non-responders to OM 40 mg were treated with OM/HCTZ 40/12.5 mg for an additional 8 weeks.
  • Non-responders to OM/HCTZ 40/12.5 mg were uptitrated to OM/HCTZ 40/25 mg for an additional 8 weeks. During Phase B of the study, visits were held 12 and 16 weeks after randomisation (Visits 5 and 6, respectively).

The study ended at Visit 6 and a final examination was performed. A safety follow-up (SFU) telephone contact was performed 2 weeks after the end of the treatment. An SFU visit was performed if deemed necessary by the investigator.

Sphygmomanometer was used for BP measurement throughout the trial. BP was measured at all visits as nearly as possible at the same time of the day as trough readings (24 ± 2 h after last drug intake) after a 10 minute rest period. Three separate sitting BP measurements were taken at least 1 minute apart from each other. The 3 results were then averaged and rounded to a whole integer.

Patients with sBP values > 200 mmHg and/or dBP values > 120 mmHg at any time during the study were to be discontinued from the study.

Conditions
Hypertension
Being tested
OM 40, OM/HCTZ 40/12.5
Medical subject headings
Hypertension

What participants receive

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

  • OM 40Drug

    Also called Treatment

    Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.

  • OM/HCTZ 40/12.5Drug

    Also called Treatment

    Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.

Study groups in NCT00441350
Study groupRoleWhat they receive
OM 40Active comparatorOlmesartanmedoxomil (OM)40 mg tablets.
Receives: Drug: OM 40
OM/HCTZ 40/12.5ExperimentalOlmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.
Receives: Drug: OM/HCTZ 40/12.5

What is being measured

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

  1. dBP Change After 8 Weeks Phase A

    Reduction in Mean Trough Sitting dBP (mmHg) from Baseline (Week 0) to Week 8

    Measured: Eight weeks

  2. sBP Change After 8 Weeks Phase A

    Reduction in Mean Trough Sitting sBP (mmHg) from Baseline (Week 0) to Week 8

    Measured: Eight weeks

Secondary outcomes (2)

  1. dBP Change After 8 Weeks Phase B

    Reduction in trough sitting diastolic blood pressure after 8 weeks of additional treatment, depending on Phase A treatment and outcome (responder/non-responder).

    Measured: Eight weeks

  2. sBP Change After 8 Weeks Phase B

    Reduction in trough sitting systolic blood pressure after 8 weeks of additional treatment, depending on Phase A treatment and outcome (responder/non-responder).

    Measured: Eight weeks

Timeline

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

  1. First posted28 Feb 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionMay 2008
  4. Study completionMay 2008

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,004 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00441350
Sponsor's protocol ID
CS866CM-B-E303
Status last verified
Jun 2009
First submitted
27 Feb 2007
Last updated
28 Jul 2021
Data monitoring committee
No
Individual data sharing
No

Publications

  • Fogari R, Taddei S, Holm-Bentzen M, Baszak J, Melani L, Schumacher K. Efficacy and safety of olmesartan medoxomil 40 mg/hydrochlorothiazide 12.5 mg combination therapy versus olmesartan medoxomil 40 mg monotherapy in patients with moderate to severe hypertension: a randomized, double-blind, parallel-group, multicentre, multinational, phase III study. Clin Drug Investig. 2010;30(9):581-97. doi: 10.2165/11536710-000000000-00000.

    PubMed 20593911

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OM 40 and OM/HCTZ 40/12.5 in people with Hypertension, run by Menarini Group at 65 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 0 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Germany, Czechia, Israel, Italy, Poland 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 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?

Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

dBP Change After 8 Weeks Phase A (time frame: Eight 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 NCT00441350, 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 28 Jul 2021.

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