Essential HypertensionPhase 3NCT01237223

Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

A Phase 3 study testing Aliskiren/Amlodipine 150/2.5 mg, Aliskiren/amlodipine 150/5 mg and Aliskiren 150 mg in people with Essential Hypertension, run by Novartis at 11 sites in Japan.

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 purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure [msDBP] ≥ 95 mmHg and < 110 mmHg and mean sitting systolic blood pressure… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Essential Hypertension
What is being tested?: Aliskiren/Amlodipine 150/2.5 mg, Aliskiren/amlodipine 150/5 mg and Aliskiren 150 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,342 participants
Where: 11 sitesJapan
Study dates: Oct 2010to May 2011
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with essential hypertension (msDBP ≥ 95 mmHg and < 110 mmHg and msSBP ≥140 mmHg )
Outpatients

Who cannot join

Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers
History or evidence of a secondary hypertension
Other protocol-defined inclusion/exclusion criteria applied

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Japan11 sites

Investigative Site
Aichi
Investigative Site
Ehime
Investigative Site
Fukuoka
Investigative Site
Hokkaido
Investigative Site
Hyōgo
Investigative Site
Kanagawa
Investigative Site
Kyoto
Investigative Site
Okayama
Investigative Site
Osaka
Investigative Site
Saitama
Investigative Site
Tokyo

Other trials in Japan

About this study

Official title: An 8-week Double-blind, Multicenter, Randomized, 6-arm, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in Patients With Essential Hypertension

Conditions: Essential Hypertension
Being tested: Aliskiren/Amlodipine 150/2.5 mg, Aliskiren/amlodipine 150/5 mg, Aliskiren 150 mg, Amlodipine 2.5 mg, Placebo of Aliskiren
Keywords: Aliskiren, Amlodipine, Essential hypertension
Medical subject headings: Essential Hypertension

What participants receive

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

Aliskiren/Amlodipine 150/2.5 mgDrug
Aliskiren/amlodipine 150/2.5 mg tablet
Aliskiren/amlodipine 150/5 mgDrug
Aliskiren/amlodipine 150/5 mg tablet
Aliskiren 150 mgDrug
Aliskiren 150 mg tablet
Amlodipine 2.5 mgDrug
Amlodipine 2.5 mg capsule
Placebo of AliskirenDrug
Aliskiren placebo tablet
Placebo of AmlodipineDrug
Amlodipine placebo capsule
Placebo of Aliskiren/amlodipine 150/2.5 mgDrug
Aliskiren/amlodipine 150/2.5 mg placebo tablet
Placebo of Aliskiren/amlodipine 150/5 mgDrug
Aliskiren/amlodipine 150/5 mg placebo tablet

Study groups in NCT01237223
Study group	Role	What they receive
Placebo	Placebo comparator	In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily. Receives: Drug: Placebo of Aliskiren; Drug: Placebo of Amlodipine; Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg; Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Aliskiren 150 mg	Active comparator	In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. Receives: Drug: Aliskiren 150 mg; Drug: Placebo of Amlodipine; Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg; Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Amlodipine 2.5 mg	Active comparator	In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. Receives: Drug: Amlodipine 2.5 mg; Drug: Placebo of Aliskiren; Drug: Placebo of Amlodipine; Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg; Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Amlodipine 5 mg	Active comparator	In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. Receives: Drug: Amlodipine 2.5 mg; Drug: Placebo of Aliskiren; Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg; Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/2.5 mg	Experimental	In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. Receives: Drug: Aliskiren/Amlodipine 150/2.5 mg; Drug: Placebo of Aliskiren; Drug: Placebo of Amlodipine; Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg	Experimental	In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. Receives: Drug: Aliskiren/amlodipine 150/5 mg; Drug: Placebo of Aliskiren; Drug: Placebo of Amlodipine; Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg

What is being measured

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

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
Measured: Baseline, Week 8

Secondary outcomes (4)

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
Measured: Baseline, Week 8
Percentage of Participants Achieving Blood Pressure Control at Endpoint
Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.
Measured: 8 weeks
Percentage of Participants Achieving a Successful Response Rate
The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.
Measured: 8 weeks
Number of Participants With Adverse Events, Serious Adverse Events and Death
Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported.
Measured: 8 weeks

Timeline

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

Oct 2010May 2011

First posted9 Nov 2010 (estimated)
Study startOct 2010
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Essential HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Who is masked: Participant, Outcomes assessor
Enrolment: 1,342 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01237223
Sponsor's protocol ID: CSPA100A1301
Status last verified: May 2012
First submitted: 29 Oct 2010
Last updated: 13 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
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Recruiting
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All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-week Double-blind, Multicenter, Randomized, 6-arm, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in Patients With Essential Hypertension
ClinicalTrials.gov ID: NCT01237223
Acronym / sponsor ID: CSPA100A1301
Conditions: Essential Hypertension
Keywords: Aliskiren, Amlodipine, Essential hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,342 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 9 Nov 2010 (estimated)
Results: Posted 13 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo of Aliskiren, Drug: Placebo of Amlodipine, Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg, Drug: Placebo of Aliskiren/amlodipine 150/5 mgIn order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
Aliskiren 150 mg	Active comparator	Drug: Aliskiren 150 mg, Drug: Placebo of Amlodipine, Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg, Drug: Placebo of Aliskiren/amlodipine 150/5 mgIn order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
Amlodipine 2.5 mg	Active comparator	Drug: Amlodipine 2.5 mg, Drug: Placebo of Aliskiren, Drug: Placebo of Amlodipine, Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg, Drug: Placebo of Aliskiren/amlodipine 150/5 mgIn order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
Amlodipine 5 mg	Active comparator	Drug: Amlodipine 2.5 mg, Drug: Placebo of Aliskiren, Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg, Drug: Placebo of Aliskiren/amlodipine 150/5 mgIn order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
Aliskiren/amlodipine 150/2.5 mg	Experimental	Drug: Aliskiren/Amlodipine 150/2.5 mg, Drug: Placebo of Aliskiren, Drug: Placebo of Amlodipine, Drug: Placebo of Aliskiren/amlodipine 150/5 mgIn order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
Aliskiren/amlodipine 150/5 mg	Experimental	Drug: Aliskiren/amlodipine 150/5 mg, Drug: Placebo of Aliskiren, Drug: Placebo of Amlodipine, Drug: Placebo of Aliskiren/amlodipine 150/2.5 mgIn order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with essential hypertension (msDBP ≥ 95 mmHg and < 110 mmHg and msSBP ≥140 mmHg )
Outpatients

Key exclusion criteria (4 listed)

Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers
History or evidence of a secondary hypertension
Other protocol-defined inclusion/exclusion criteria applied

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aliskiren/Amlodipine 150/2.5 mgAliskiren/amlodipine 150/2.5 mg tablet	Drug	Aliskiren/amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/5 mgAliskiren/amlodipine 150/5 mg tablet	Drug	Aliskiren/amlodipine 150/5 mg
Aliskiren 150 mgAliskiren 150 mg tablet	Drug	Aliskiren 150 mg
Amlodipine 2.5 mgAmlodipine 2.5 mg capsule	Drug	Amlodipine 2.5 mg, Amlodipine 5 mg
Placebo of AliskirenAliskiren placebo tablet	Drug	Aliskiren/amlodipine 150/2.5 mg, Aliskiren/amlodipine 150/5 mg, Amlodipine 2.5 mg, Amlodipine 5 mg, Placebo
Placebo of AmlodipineAmlodipine placebo capsule	Drug	Aliskiren 150 mg, Aliskiren/amlodipine 150/2.5 mg, Aliskiren/amlodipine 150/5 mg, Amlodipine 2.5 mg, Placebo
Placebo of Aliskiren/amlodipine 150/2.5 mgAliskiren/amlodipine 150/2.5 mg placebo tablet	Drug	Aliskiren 150 mg, Aliskiren/amlodipine 150/5 mg, Amlodipine 2.5 mg, Amlodipine 5 mg, Placebo
Placebo of Aliskiren/amlodipine 150/5 mgAliskiren/amlodipine 150/5 mg placebo tablet	Drug	Aliskiren 150 mg, Aliskiren/amlodipine 150/2.5 mg, Amlodipine 2.5 mg, Amlodipine 5 mg, Placebo

Primary outcome

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)
Time frame: Baseline, Week 8
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.

4 secondary outcomes

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)
Time frame: Baseline, Week 8
Percentage of Participants Achieving Blood Pressure Control at Endpoint
Time frame: 8 weeks
Percentage of Participants Achieving a Successful Response Rate
Time frame: 8 weeks
Number of Participants With Adverse Events, Serious Adverse Events and Death
Time frame: 8 weeks

Results and safety

Results posted to the registry on 13 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	1,342	944
Aliskiren 150 mg	0	0
Amlodipine 2.5 mg	0	0
Amlodipine 5 mg	0	0
Aliskiren/Amlodipine 150/2.5 mg	0	0
Aliskiren/Amlodipine 150/5 mg	0	0

Primary outcome: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)

Time frame: Baseline, Week 8. Least squares mean (Standard Error). Unit: mm Hg

Measure	Placebo n = 153	Aliskiren 150 mg n = 157	Amlodipine 2.5 mg n = 158	Amlodipine 5 mg n = 158	Aliskiren/Amlodipine 150/2.5 mg n = 159	Aliskiren/Amlodipine 150/5 mg n = 159
Value	-5.21 (0.69)	-7.49 (0.68)	-9.46 (0.68)	-11.90 (0.68)	-12.40 (0.68)	-16.43 (0.68)

Population analysed: Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Double Blind)	0 of 153 (0%)	21 of 153 (13.7%)	Not reported
Aliskiren 150 mg	0 of 157 (0%)	21 of 157 (13.4%)	Not reported
Amlodipine 2.5 mg	2 of 158 (1.3%)	17 of 158 (10.8%)	Not reported
Amlodipine 5 mg	1 of 158 (0.6%)	21 of 158 (13.3%)	Not reported
Aliskiren/Amlodipine 150/2.5 mg	0 of 159 (0%)	17 of 159 (10.7%)	Not reported
Aliskiren/Amlodipine 150/5 mg	1 of 159 (0.6%)	19 of 159 (11.9%)	Not reported
Placebo (Single-Blind run-in Period)	4 of 1,342 (0.3%)	136 of 1,342 (10.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aliskiren/Amlodipine 150/2.5 mg, Aliskiren/amlodipine 150/5 mg and Aliskiren 150 mg in people with Essential Hypertension, run by Novartis at 11 sites in Japan.

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 2 inclusion and 4 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 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Japan. 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. Some participants in this study may receive a placebo. 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 13 Jun 2012). 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?

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8) (time frame: Baseline, Week 8). 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 NCT01237223.

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 13 Jun 2012.