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AzTrials

Stage II HypertensionPhase 4ACADEMYNCT01070030

Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II Hypertension

A Phase 4 study testing Aliskiren/Amlodipine (150/5 mg/day, 300/10 mg/day) , Aliskiren/Amlodipine/Hydrochlorothiazide (300/10/12.5 mg/day, 300/10/25 mg/day) in people with Stage II Hypertension, run by Novartis at 3 sites in Thailand.

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

This study assessed the efficacy and safety of combination therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in patients with stage II Hypertension. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage II Hypertension
What is being tested?
Aliskiren/Amlodipine (150/5 mg/day, 300/10 mg/day) , Aliskiren/Amlodipine/Hydrochlorothiazide (300/10/12.5 mg/day, 300/10/25 mg/day)
How many people
230 participants
Where
3 sitesThailand
Study dates
Jan 2010to Oct 2010
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Outpatients 18 years of age or older
  • Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicidal or an intrauterine device.
  • Patients with a diagnosis of hypertension as following msDBP \& msSBP Requirements:
  • For newly diagnosed/untreated patients:
  • Mean Sitting Diastolic Blood Pressure (msDBP) ≥ 100 and < 120 mmHg, and/or mean sitting Systolic Blood Pressure (msSBP) ≥ 160 and < 200 mmHg at Visit1.
  • For previously treated patients with 1 or 2 antihypertensive medications:
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  • msDBP ≥ 90 and < 100 mmHg, and/or msSBP ≥ 140 and < 160 mmHg at Visit 1 AND
  • msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160 and < 200 mmHg at Visit 2.
  • For previously treated patients with Atenolol 50 mg once daily alone more than 2 weeks consecutively at visit 1:
  • msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160 and < 200 mmHg.
  • Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

Who cannot join

  • Patients that previously participated in any Aliskiren study.
  • Inability to receive or completely replace all previous antihypertensive medications with Atenolol 50 mg once daily for a period of 2 weeks as required by the protocol.
  • Patients on 1 (other than Atenolol 50 mg once daily) or 2 antihypertensive drugs with msDBP ≥ 100 mmHg and/or msSBP ≥ 160 mmHg at Visit 1.
  • Patients on 3 or more antihypertensive drugs at Visit 1.
  • Pregnant or nursing (lactating) women, when pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (≥ 5 mIU/mL).
  • Sexually active female patients who are not using effective contraceptive methods.
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  • Serum potassium <3.5 mEq/L (mmol/L) or > 5.5 mEq/L at Visit 1.
  • Second or third degree heart block with or without a pacemaker, or other potentially life-threatening or symptomatic arrhythmia current or by history.
  • History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

3 sites in 1 country.

Thailand3 sites

  • Investigative Site

    Bangkok

  • Investigative Site

    Chiang Mai

  • Investigative Site

    Nakhon Ratchasima

Other trials in Thailand

About this study

Official title: Multi-center, Open Label, 18-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II HT

This study assessed the efficacy and safety of combination therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in patients with stage II Hypertension.

Being tested
Aliskiren/Amlodipine (150/5 mg/day, 300/10 mg/day) , Aliskiren/Amlodipine/Hydrochlorothiazide (300/10/12.5 mg/day, 300/10/25 mg/day)
Keywords
Stage II Hypertension, Aliskiren, Amlodipine, Hydrochlorothiazide
Medical subject headings
Hypertension

What participants receive

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

  • Aliskiren/Amlodipine (150/5 mg/day, 300/10 mg/day) , Aliskiren/Amlodipine/Hydrochlorothiazide (300/10/12.5 mg/day, 300/10/25 mg/day)Drug

    The patients were asked for 2 week run-in phase with atenolol 50 mg qd(once a day), followed by 4 schedule visits with 4-week interval until patient achieved BP goal. The maximum follow up was 16-week treatment. At visit 2, the patients started receiving Aliskiren/Amlodipine (150/5mg per day) for 4 weeks. At visit 3, if the patients did not achieve blood pressure (BP) goal, patients were up titrated to Aliskiren/Amlodipine (300/10 mg/day) for 4 weeks. At visit 4, if the patients did not achieve BP goal, HCT 12.5 mg/day was added to Aliskiren/Amlodipine/HCT (300/10/12.5 mg/day) for 4 weeks. Finally at visit 5, if the patients did not achieve BP goal, HCT was up titrated to Aliskiren/Amlodipine/HCT (300/10/25 mg/day) for 4 weeks until visit 6. Once the patients achieved BP goal at any visit, they completed the study.

What is being measured

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

  1. Percentage of participants with stage II hypertension achieving blood pressure (BP) goal

    The BP goal for non-diabetic patient is defined as msSBP < 140 mmHg and msDBP < 90 mmHg. The BP goal for diabetic patient is msSBP < 130 mmHg and msDBP < 80 mmHg) in patients with stage II hypertension.

    Measured: 18 weeks

Secondary outcomes (4)

  1. Percentage of participants who have blood pressure surge to their baseline level during 24-h ambulatory blood pressure monitor (ABPM)

    24-h ABPM profiles were assessed by percentage of participants who have blood pressure (BP) surge to their baseline level (during 24-h ABPM) once after patients achieve BP goal (BP goal for non-diabetic patient is defined as msSBP < 140 mmHg and msDBP < 90 mmHg; and the BP goal for diabetic patient is msSBP < 130 mmHg and msDBP < 80) at any visit only in selected study sites. The mean 24-hour MADBP (Mean Ambulatory Diastolic Blood Pressure) or MASBP (Mean Ambulatory Systolic Blood Pressure) is defined as the average of the hourly MADBP or MASBP over 24 hours respectively.

    Measured: 18 weeks

  2. Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to study end

    mSBP and mDBP is defined as an average of 2 points blood pressure measurements which 5 minutes apart. Patient must be at rest for at least 5 minutes in sitting position before the heart rate and blood pressure measurement. The arm for blood pressure measurement should be the same during the whole study.

    Measured: From baseline to study completion (between week 8 to 18)

  3. Number of participants with responder rate for Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

    The responder rate of msSBP is defined as msSBP < 140 mmHg for non-diabetic patients (msSBP < 130 mmHg for diabetic patients) or by a reduction of ≥ 20 mmHg BP from baseline.

    The responder rate of msDBP is defined as msDBP < 90 mmHg for non-diabetic patients ( msDBP < 80 mmHg for diabetic patients) or by a reduction of ≥ 10 mm Hg BP from baseline

    Measured: 18 weeks

  4. Number of patients with any adverse events

    An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the medicinal (investigational) product.

    Measured: 18 weeks

Timeline

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

  1. First posted17 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionOct 2010
  4. Study completionOct 2010

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01070030
Sponsor's protocol ID
CSPP100ATH01
Acronym
ACADEMY
Status last verified
Feb 2017
First submitted
16 Feb 2010
Last updated
23 Feb 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aliskiren/Amlodipine (150/5 mg/day, 300/10 mg/day) , Aliskiren/Amlodipine/Hydrochlorothiazide (300/10/12.5 mg/day, 300/10/25 mg/day) in people with Stage II Hypertension, run by Novartis at 3 sites in Thailand.

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 11 inclusion and 10 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Thailand. 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?

Percentage of participants with stage II hypertension achieving blood pressure (BP) goal (time frame: 18 weeks). 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 NCT01070030.

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 23 Feb 2017.

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