HypertensionPhase 3NCT00368277
A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly
A Phase 3 study testing Aliskiren, Ramipril and Hydrochlorothiazide in people with Hypertension, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Aliskiren, Ramipril and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 901 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female outpatients ≥ 65 years old.
- Patients with essential hypertension with an msSBP ≥ 140 mmHg and < 180 mmHg, and msDBP < 110 mmHg at Visits 2 and 3. (Visit 201 was deleted by the Administrative Changes document.)
- Patients must have had a difference in msSBP of ≤ 20 mmHg between Visit 3 and the visit immediately prior to Visit 3.
- Patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent).
Who cannot join
- History of renal artery stenosis.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of hypertensive encephalopathy.
- Current diagnosis of heart failure (New York Heart Association Class III-IV).
- History of transient ischemic cerebral attack or cerebrovascular accident within 6 months.
- History of myocardial infarction, bypass surgery, or any percutaneous coronary intervention within 6 months.
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- Current unstable angina pectoris. Patients on a stable dose of oral or topical nitrates or beta blockers for angina were acceptable.
- Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- Clinically significant valvular heart disease.
- Concurrent use of any antihypersensitive medications except a stable dose 3 months prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., Flomax for BPH), beta blockers for angina, or beta blockers ophthalmic preparations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: A 36 Week Randomized, Double-blind, Parallel Group, Multi-center, Active-controlled, Optional Titration Study Comparing an Aliskiren-based Regimen to a Ramipril-based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension
Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.
- Conditions
- Hypertension
- Being tested
- Aliskiren, Ramipril, Hydrochlorothiazide, Amlodipine
- Keywords
- Systolic hypertension, hypertension, aliskiren, blood pressure, ramipril, HTN
- Medical subject headings
- Hypertension, Isolated Systolic Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning
RamiprilDrug
Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning
HydrochlorothiazideDrug
Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning
AmlodipineDrug
Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren-based regimen | Experimental | Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg Receives: Drug: Aliskiren; Drug: Hydrochlorothiazide; Drug: Amlodipine |
| Ramipril-based regimen | Active comparator | Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg Receives: Drug: Ramipril; Drug: Hydrochlorothiazide; Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12
Measured: Baseline and Week 12
Secondary outcomes (3)
Percentage of Patients With Cough
Measured: Weeks 12 and 36
Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints
Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg
Measured: Weeks 12 and 36
Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36
Measured: Baseline and week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368277
- Sponsor's protocol ID
- CSPP100A2344
- Status last verified
- Feb 2011
- First submitted
- 22 Aug 2006
- Last updated
- 25 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
PubMed 33089502
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 36 Week Randomized, Double-blind, Parallel Group, Multi-center, Active-controlled, Optional Titration Study Comparing an Aliskiren-based Regimen to a Ramipril-based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension
- ClinicalTrials.gov ID
- NCT00368277
- Acronym / sponsor ID
- CSPP100A2344
- Conditions
- Hypertension
- Keywords
- Systolic hypertension, hypertension, aliskiren, blood pressure, ramipril, HTN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 24 Aug 2006 (estimated)
- Results
- Posted 25 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aliskiren-based regimen | Experimental | Drug: Aliskiren, Drug: Hydrochlorothiazide, Drug: AmlodipineAliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg |
| Ramipril-based regimen | Active comparator | Drug: Ramipril, Drug: Hydrochlorothiazide, Drug: AmlodipineRamipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Male or female outpatients ≥ 65 years old.
- Patients with essential hypertension with an msSBP ≥ 140 mmHg and < 180 mmHg, and msDBP < 110 mmHg at Visits 2 and 3. (Visit 201 was deleted by the Administrative Changes document.)
- Patients must have had a difference in msSBP of ≤ 20 mmHg between Visit 3 and the visit immediately prior to Visit 3.
- Patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent).
Key exclusion criteria (10 listed)
- History of renal artery stenosis.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of hypertensive encephalopathy.
- Current diagnosis of heart failure (New York Heart Association Class III-IV).
- History of transient ischemic cerebral attack or cerebrovascular accident within 6 months.
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 |
|---|---|---|
| AliskirenAliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning | Drug | Aliskiren-based regimen |
| RamiprilRamipril 5 mg and 10 mg capsules taken orally, once a day in the morning | Drug | Ramipril-based regimen |
| HydrochlorothiazideHydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning | Drug | Aliskiren-based regimen, Ramipril-based regimen |
| AmlodipineAmlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning | Drug | Aliskiren-based regimen, Ramipril-based regimen |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12
Time frame: Baseline and Week 12
3 secondary outcomes
Percentage of Patients With Cough
Time frame: Weeks 12 and 36
Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints
Time frame: Weeks 12 and 36
Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36
Time frame: Baseline and week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33089502Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
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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
1 site 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, Ramipril and Hydrochlorothiazide in people with Hypertension, run by Novartis Pharmaceuticals at 1 site in United States.
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 4 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 25 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 25 Mar 2011). 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 Systolic Blood Pressure to Week 12 (time frame: Baseline and Week 12). 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 NCT00368277, 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 25 Mar 2011.