CClinicalTrials.gg
Sign In
CompletedNCT00430508Updated Jan 9, 2019Results posted

Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

A Phase 3 interventional study of olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo and olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets in Essential Hypertension, sponsored by Daiichi Sankyo. Completed at 55 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by Daiichi Sankyo · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
972
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.

02

Conditions studied

  • Essential Hypertension

Keywords

  • Moderate-to-Severe Hypertension
  • Essential Hypertension
  • Combination Therapy
  • Fixed-Combination Dose
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 972 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female Europeans aged 18 years or older with moderate to severe hypertension (HTN)

Exclusion criteria

Exclusion Criteria:

  • Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
  • Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.

  • Patients having a history of the following within the last six months:

    • myocardial infarction,
    • unstable angina pectoris,
    • percutaneous coronary intervention,
    • severe heart failure,
    • hypertensive encephalopathy,
    • cerebrovascular accident (stroke) or
    • transient ischaemic attack.
  • Patients with clinically significant abnormal laboratory values at screening.
  • Patients with secondary HTN.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
972 participants (actual)

Study arms

  • Experimental
    4

    olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

    Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo

  • Experimental
    1

    olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

    Drug: olmesartan medoxomil/hydrochlorothiazide tablets

  • Experimental
    3

    olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks

    Drug: olmesartan medoxomil/hydrochlorothiazide tablets

  • Experimental
    2

    olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

    Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets

Interventions

  • Drugolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo

    olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week

  • Drugolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets

    olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

  • Drugolmesartan medoxomil/hydrochlorothiazide tablets

    olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

  • Drugolmesartan medoxomil/hydrochlorothiazide tablets

    olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks

06

What researchers measure

Primary outcomes

  1. Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16

    Change = Week 16 - Week 8 (baseline).

    Time frame: 8 weeks, change = week 16 - week 8

Secondary outcomes

  1. Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.

    Change = Week 12 - Week 8 (baseline).

    Time frame: 4 weeks, change = week 12 - week 8

  2. Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.

    Change = Week 16 - Week 8 (baseline).

    Time frame: 8 weeks, change = week 16 - week 8

  3. Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.

    Change = Week 12 - Week 8 (baseline).

    Time frame: 4 weeks, change = week 12 - week 8

  4. Number of Patients Achieving Target Blood Pressure at Week 16

    Target Blood Pressure is diastolic blood pressure (dBP) \< 90 mmHg and systolic blood pressure (sBP) \< 140 mmHg for non-diabetics, and dBP \< 80 mmHg and sBP \< 130 mmHg for diabetics

    Time frame: 8 weeks

  5. Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

    Change = Week 16 - Week 8 (baseline).

    Time frame: 8 weeks, change = week 16 - week 8

  6. Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

    Change = Week 16 - Week 8 (baseline).

    Time frame: 8 weeks, change = week 16 - week 8

  7. Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

    Change = Week 16 - Week 8 (baseline).

    Time frame: 8 weeks, change = week 16 - week 8

07

Results

Posted Jun 17, 2009

Participant flow

78 investigative sites screened patients in Europe (19 in Czech Republic, 11 in Germany, 8 in Bulgaria, 5 in Spain, 20 in Ukraine, 1 in France and 14 in Poland). Sites were either hospitals or general practitioners. First patient in: 17 January 2007 Last patient out: 30 March 2008

Participant flow — Overall Study
MilestoneOM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Started140278279274
Completed137272266269
Not completed36135
Withdrew: Adverse event2353
Withdrew: Withdrawal by subject0111
Withdrew: Responder at visit 40020
Withdrew: Conmed-bp-pulse-abpm withdrawal criteria0121
Withdrew: Other1130

Outcome measures

PrimaryChange in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16

Change = Week 16 - Week 8 (baseline).

Time frame:
8 weeks, change = week 16 - week 8
Reported as:
Mean · mm Hg
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
mm HgOM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16-11.16 ± 8.796-9.13 ± 8.622-8.10 ± 7.968-5.66 ± 8.546
Statistical analysis
  • OM/HCTZ 40/25mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -5.3 · 95% CI -6.97 to -3.6
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -3.4 · 95% CI -4.79 to -2.03
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 20/12.5mg + 40/0 Matching Placebo · ANCOVA · p = 0.1788 · Mean difference (net): -0.9 · 95% CI -2.32 to 0.43
SecondaryChange in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.

Change = Week 12 - Week 8 (baseline).

Time frame:
4 weeks, change = week 12 - week 8
Reported as:
Mean · mm Hg
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.
mm HgOM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.-8.74 ± 7.879-7.72 ± 7.606-6.66 ± 7.090-4.47 ± 7.197
Statistical analysis
  • OM/HCTZ 40/25mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -4.1 · 95% CI -5.54 to -2.6
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -3.2 · 95% CI -4.39 to -1.98
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 20/12.5mg + 40/0 Matching Placebo · ANCOVA · p = 0.1081 · Mean difference (net): -1.0 · 95% CI -2.19 to 0.22
SecondaryChange in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Time frame:
8 weeks, change = week 16 - week 8
Reported as:
Mean · mm Hg
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.
mm HgOM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.-16.17 ± 13.444-13.52 ± 14.533-11.46 ± 13.673-8.85 ± 13.537
Statistical analysis
  • OM/HCTZ 40/25mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -7.4 · 95% CI -10.13 to -4.66
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -5.2 · 95% CI -7.4 to -2.91
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 20/12.5mg + 40/0 Matching Placebo · ANCOVA · p = 0.0255 · Mean difference (net): -2.6 · 95% CI -4.79 to -0.31
SecondaryChange in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.

Change = Week 12 - Week 8 (baseline).

Time frame:
4 weeks, change = week 12 - week 8
Reported as:
Mean · mm Hg
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.
mm HgOM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.-13.16 ± 13.337-10.90 ± 12.297-9.65 ± 11.743-6.60 ± 10.932
Statistical analysis
  • OM/HCTZ 40/25mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -6.6 · 95% CI -9.00 to -4.26
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -4.8 · 95% CI -6.70 to -2.81
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 20/12.5mg + 40/0 Matching Placebo · ANCOVA · p = 0.0812 · Mean difference (net): -1.7 · 95% CI -3.66 to 0.21
SecondaryNumber of Patients Achieving Target Blood Pressure at Week 16

Target Blood Pressure is diastolic blood pressure (dBP) \< 90 mmHg and systolic blood pressure (sBP) \< 140 mmHg for non-diabetics, and dBP \< 80 mmHg and sBP \< 130 mmHg for diabetics

Time frame:
8 weeks
Reported as:
Number · participants
Number of Patients Achieving Target Blood Pressure at Week 16
participantsOM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Number of Patients Achieving Target Blood Pressure at Week 16591108868
Statistical analysis
  • OM/HCTZ 40/25mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · Regression, Logistic · Odds ratio (or): 2.67 · 95% CI 1.69 to 4.21
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · Regression, Logistic · Odds ratio (or): 2.20 · 95% CI 1.50 to 3.24
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 20/12.5mg + 40/0 Matching Placebo · Regression, Logistic · Odds ratio (or): 1.55 · 95% CI 1.07 to 2.25
SecondaryChange in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Time frame:
8 weeks, change = week 16 - week 8
Reported as:
Mean · mm Hg
Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
mm HgOM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.-7.2 ± 7.62-5.3 ± 8.60-4.1 ± 9.07-2.0 ± 7.64
Statistical analysis
  • OM/HCTZ 40/25mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -5.1 · 95% CI -6.78 to -3.36
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -3.2 · 95% CI -4.54 to -1.78
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 20/12.5mg + 40/0 Matching Placebo · ANCOVA · p = 0.1452 · Mean difference (net): -1.0 · 95% CI -2.43 to 0.36
SecondaryChange in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Time frame:
8 weeks, change = week 16 - week 8
Reported as:
Mean · mm Hg
Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
mm HgOM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.-7.0 ± 8.06-5.5 ± 9.10-4.0 ± 9.34-1.8 ± 8.39
Statistical analysis
  • OM/HCTZ 40/25mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -5.0 · 95% CI -6.79 to -3.17
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -3.3 · 95% CI -4.79 to -1.87
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 20/12.5mg + 40/0 Matching Placebo · ANCOVA · p = 0.1629 · Mean difference (net): -1.0 · 95% CI -2.52 to 0.42
SecondaryChange in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Time frame:
8 weeks, change = week 16 - week 8
Reported as:
Mean · mm Hg
Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
mm HgOM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.-7.9 ± 9.51-4.5 ± 9.90-4.2 ± 10.61-2.3 ± 8.47
Statistical analysis
  • OM/HCTZ 40/25mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -5.5 · 95% CI -7.40 to -3.62
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo · ANCOVA · p = <0.0009 · Mean difference (net): -2.6 · 95% CI -4.12 to -1.07
  • OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 20/12.5mg + 40/0 Matching Placebo · ANCOVA · p = 0.1985 · Mean difference (net): -1.0 · 95% CI -2.55 to 0.53

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)OM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching PlaceboTotal
<=18 years00000
Between 18 and 65 years122240233238833
>=65 years18384636138
Age, Continuous
Age, Continuous(years)OM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching PlaceboTotal
Mean55.2 ± 8.1753.7 ± 9.7755.2 ± 9.4754.1 ± 8.9254.5 ± 9.24
Sex: Female, Male
Sex: Female, Male(Participants)OM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching PlaceboTotal
Female52105100115372
Male88173179159599
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)OM/HCTZ 40/25mg + 20/12.5 Matching PlaceboOM/HCTZ 40/12.5mg + 20/12.5 Matching PlaceboOM/HCTZ 20/12.5mg + 40/0 Matching PlaceboOM/HCTZ 40/0mg + 20/12.5 Matching PlaceboTotal
European140278278274970.0
Other00101.0
08

Study locations

55 sites
  • Pleven, Bulgaria
  • Sofia, Bulgaria
  • Beroun, Czechia
  • Brno, Czechia
  • Chrudim, Czechia
  • Hradec Kralove, Czechia
  • Jindrichuv Hradec, Czechia
  • Kutna Hora, Czechia
  • Ostrava, Czechia
  • Pardubice, Czechia
  • Plzen, Czechia
  • Prague, Czechia
  • Pribram, Czechia
  • Revnice, Czechia
  • Sokolov, Czechia
  • Trutnov, Czechia
  • Langres, France
  • Paris, France
  • Pessac, France
  • Berlin, Germany
  • Bochum, Germany
  • Dietzenbach, Germany
  • Franfurt, Germany
  • Friedberg, Germany
  • Ingelheim, Germany
  • Karlsbad, Germany
  • Leipzig, Germany
  • Offenbach, Germany
  • Siegen, Germany
  • Stuhr-Brinkum, Germany
  • Elblag, Poland
  • Gdansk, Poland
  • Inowroclaw, Poland
  • Katowice, Poland
  • Krakow, Poland
  • Linia, Poland
  • Lodz, Poland
  • Olawa, Poland
  • Poznan, Poland
  • Warszawa, Poland
  • Wroclaw, Poland
  • Zamosc, Poland
  • Girona, Spain
  • Granada, Spain
  • Madrid, Spain
  • Oviedo, Spain
  • Dnepropetrovsk, Ukraine
  • Donetsk, Ukraine
  • Kharkiv, Ukraine
  • Kiev, Ukraine
  • Lviv, Ukraine
  • Odessa, Ukraine
  • Uzhgorod, Ukraine
  • Vinnytsia, Ukraine
  • Zaporizhzhya, Ukraine
09

References and documents

Publications

  • Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9. PubMed 22114906 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00430508
Lead sponsor
Daiichi Sankyo
Collaborators
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
First posted
Feb 2, 2007
Start date
Feb 2007
Primary completion
Mar 2008
Completion
May 2008
Results posted
Jun 17, 2009
Last update
Jan 9, 2019

Study contacts

Professor Lars Christian Rump, M.D.
study chair · University of Ruhr-Bochum

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertension→

Other studies from this sponsor

Daiichi Sankyo

Start the discussion