Essential HypertensionPhase 4ALIASNCT01042392

Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients

A Phase 4 study testing Aliskiren and Ramipril in people with Essential Hypertension, run by Novartis at 98 sites in France.

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 prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Essential Hypertension
What is being tested?: Aliskiren and Ramipril
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 506 participants
Where: 98 sitesFrance
Study dates: Nov 2009to Jan 2011
Phase: Phase 4
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

Outpatients > 18 years
Male or female patients. Female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
Patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
BP thresholds at visit 1:
For patients previously treated and uncontrolled: 140≤ office SBP<180 mmHg
For patients previously treated, controlled but intolerant: office SBP≥130 mmHg

Show all 9Show fewer

BP thresholds at visit 2 (for all patients):
160≤office SBP<180 mmHg AND
155≤home SBP<175 mmHg (3-day period of home blood pressure monitoring just before randomization)

Who cannot join

Women of child-bearing potential not using any effective methods of contraception
Severe hypertension (office BP ≥ 180/110 mmHg)
Impossibility to stop abruptly previous antihypertensive treatments at visit 1
Patients previously untreated or patients treated with two or three antihypertensive medications
History or evidence of a secondary form of hypertension
History of hypersensitivity to ACEi or renin inhibitors

Show all 9Show fewer

History of heart failure, stroke or coronary heart disease
Serum potassium ≥ 5.2 mmol/l
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

98 sites in 1 country.

City, postcode or hospital

98 sites in 1 country

France98 sites

Novartis Investigative Site
Aire Sur Adour
Novartis Investigative Site
Amboise
Novartis Investigative Site
Angers
Novartis Investigative Site
Anzin
Novartis Investigative Site
Bachant
Novartis Investigative Site
Bandol
Novartis Investigative Site
Bécon-les-Granits
Novartis Investigative Site
Bersée
Novartis Investigative Site
Bordeaux
Novartis Investigative Site
Bouliac
Novartis Investigative Site
Bourges
Novartis Investigative Site
Briollay
Novartis Investigative Site
Bruges
Novartis Investigative Site
Caen
Novartis Investigative Site
Carbonne
Novartis Investigative Site
Château-Gontier
Novartis Investigative Site
Châtellerault
Novartis Investigative Site
Chatillon Sur Colmon
Novartis Investigative Site
Cherbourg
Novartis Investigative Site
Cournonterral
Novartis Investigative Site
Croix
Novartis Investigative Site
Cugnaux
Novartis Investigative Site
Écouflant
Novartis Investigative Site
Équeurdreville-Hainneville
Novartis Investigative Site
Falaise
Novartis Investigative Site
Fondettes
Novartis Investigative Site
Guérigny
Novartis Investigative Site
Hautmont
Novartis Investigative Site
L'Aigle
Novartis Investigative Site
La Farlède
Novartis Investigative Site
La Riche
Novartis Investigative Site
La Rochelle
Novartis Investigative Site
Labarthe-sur-Lèze
Novartis Investigative Site
Lambersart
Novartis Investigative Site
Laval
Novartis Investigative Site
Le Bouscat
Novartis Investigative Site
Le Cailar
Novartis Investigative Site
Le Fousseret
Novartis Investigative Site
Le Pradet
Novartis Investigative Site
Les Maguelone
Novartis Investigative Site
Luynes
Novartis Investigative Site
Marcheprime
Novartis Investigative Site
Marseille
Novartis Investigative Site
Marsilly
Novartis Investigator Site
Marsilly
Novartis Investigative Site
Mayenne
Novartis Investigative Site
Médis
Novartis Investigative Site
Mont-de-Marsan
Novartis Investigative Site
Montpellier
Novartis Investigative Site
Montrevault
Novartis Investigative Site
Monts-sur-Guesnes
Novartis Investigative Site
Mortagne-sur-Sèvre
Novartis Investigative Site
Mourmelon-le-Petit
Novartis Investigative Site
Nantes
Novartis Investigative Site
Nevers
Novartis Investigative Site
Nieul-sur-Mer
Novartis Investigative Site
Orchies
Novartis Investigative Site
Paris
Novartis Investigative Site
Périgny
Novartis Investigative Site
Potigny
Novartis Investigative Site
Reims
Novartis Investigative Site
Roquevaire
Novartis Investigative Site
Rouen
Novartis Investigative Site
Saint-Avertin
Novartis Investigative Site
Saint-Benoît
Novartis Investigative Site
Saint-Cyr-sur-Loire
Novartis Investigative Site
Saint-Cyr-sur-Mer
Novartis Investigative Site
Saint-Georges-dOrques
Novartis Investigative Site
Saint-Germain-de-Marencennes
Novartis Investigative Site
Saint-Loubès
Novartis Investigative Site
Saint-Martin-d'Oney
Investigative Site
Saint-Orens-de-Gameville
Novartis Investigative Site
Saint-Orens-de-Gameville
Novartis Investigative Site
Saint-Rogatien
Novartis Investigative Site
Saint-Seurin-de-Cursac
Novartis Investigative Site
Saint-Xandre
Novartis Investigative Site
Sainte-Marie-de-Ré
Novartis Investigative Site
Sanary-sur-Mer
Novartis Investigative Site
Savonnières
Investigative Site
Scorbé-Clairvaux
Novartis Investigative Site
Scorbé-Clairvaux
Novartis Investigative Site
Segré
Novartis Investigative Site
Seysses
Novartis Investigative Site
Sotteville-lès-Rouen
Novartis Investigative Site
Strasbourg
Novartis Investigative Site
Thun-Saint-Amand
Novartis Investigative Site
Tiercé
Investigative Site
Toulon
Novartis Investigative Site
Toulon
Novartis Investigative Site
Toulouse
Novartis Investigative Site
Tours
Novartis Investigative Site
Trélazé
Novartis Investigative Site
Vendôme
Novartis Investigative Site
Vereneque
Novartis Investigative Site
Verzy
Novartis Investigative Site
Vierzon
Novartis Investigative Site
Vieux-Condé
Novartis Investigative Site
Witry-lès-Reims

Other trials in France

About this study

This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.

Conditions: Essential Hypertension
Being tested: Aliskiren, Ramipril, Matching placebo to Aliskiren, Matching placebo to Ramipril
Keywords: Moderate systolic hypertension - adults - aliskiren -ramipril
Medical subject headings: Essential Hypertension

What participants receive

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

AliskirenDrug
150 mg Aliskiren as film-coated tablet
RamiprilDrug
Ramipril 5 mg was given in capsule form.
Matching placebo to AliskirenDrug
The tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm.
Matching placebo to RamiprilDrug
The placebo capsule to ramipril 5 mg for period I and III. In period II, matching placebo to Ramipril was given to Aliskiren active treatment arm.

Study groups in NCT01042392
Study group	Role	What they receive
Ramipril	Active comparator	In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in. In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4. In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4). Receives: Drug: Ramipril; Drug: Matching placebo to Aliskiren
Aliskiren	Experimental	In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in. In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4. In period III (double-blind withdrawal ): At visit 4, part of the patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4). Receives: Drug: Aliskiren; Drug: Matching placebo to Ramipril
Placebo to Ramipril	Placebo comparator	In period III (double-blind withdrawal ): At visit 4, part of patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4). Receives: Drug: Matching placebo to Ramipril
Placebo to Aliskiren	Placebo comparator	In period III (double-blind withdrawal ): At visit 4, part of the patients from Aliskiren arm received placebo to Aliskiren for 1 day. The study ended at visit 5 (48 hours later than visit 4). Receives: Drug: Matching placebo to Aliskiren

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 (msSBP)
The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP as covariable.
Measured: Baseline to 8 weeks

Secondary outcomes (8)

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of variance included treatment factor and baseline value of mean sitting DBP as covariable.
Measured: Baseline to 8 weeks
Percentage of Patients With Controlled Blood Pressure
The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings.
Controlled blood pressure (BP) is defined as mean office systolic BP/ diastolic BP < 140/90 mmHg.
Measured: At 4 and 8 weeks
Number of the Participants With More Than 55 mmHg Difference Between the Mean SBP Measured at the Morning Surge and the Mean Minimal SBP Measured During the Night
Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the day before visit 4, the device attached to the ambulatory blood pressure non-dominant arm of the patient. The BP morning surge was defined as the average of the measurements taken during the first 2 hours after waking the patient. The minimal night blood pressure was defined as the average of the two lowest BP measures (the lowest hourly average) recorded during night time.
Measured: After 8 weeks
Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)
The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.
Measured: Baseline to 4 weeks
Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8
Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the eve of visit 4 (week 8), the device attached to the ambulatory blood pressure non-dominant arm of the patient. The difference between mean-hour maximum SBP mean-hour minimum SBP between 1 am and 8 am was measured.
Measured: At week 8
Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)
The sub-groups were: "Riser" = patients with >= 55 mmHg difference between the mean SPB measured at the morning surge and the mean minimal SBP measured during the night. The "Non-risers" in whom the difference is <55 mmHg. Patients called "dippers" in whom there was a decrease in average nocturnal SBP ≥ 10% compared with average daytime SBP, in contrast to patients "non-dippers " in whom this difference was <10%.
Measured: Baseline to 8 weeks
Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) From Last Active Dose Taken to After a One-day Missed-dose
The change in blood pressure was measured between visit 4 (end of the period of double-blind active treatment which was at week 8) and visit 5 (48 hours after the last active dose taken) in the group of patients who received aliskiren or placebo and those who received ramipril or placebo. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.
Measured: From 8 weeks to 48 hours after week 8
Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Measured: 8 weeks + 1 day

Timeline

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

Nov 2009Jan 2011

First posted5 Jan 2010 (estimated)
Study startNov 2009
Primary completionJan 2011
Study completionJan 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.
Publications (1)Papers the sponsor has linked to this study.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 506 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01042392
Sponsor's protocol ID: CSPP100AFR01
Other IDs: 2009-011296-80, 2009
Acronym: ALIAS
Status last verified: Mar 2012
First submitted: 1 Jan 2010
Last updated: 3 Apr 2012
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

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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All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
ClinicalTrials.gov ID: NCT01042392
Acronym / sponsor ID: ALIAS / CSPP100AFR01
Conditions: Essential Hypertension
Keywords: Moderate systolic hypertension - adults - aliskiren -ramipril
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 506 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 5 Jan 2010 (estimated)
Results: Posted 3 Apr 2012

Clinical summary

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

This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Ramipril	Active comparator	Drug: Ramipril, Drug: Matching placebo to AliskirenIn period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in. In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4. In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).
Aliskiren	Experimental	Drug: Aliskiren, Drug: Matching placebo to RamiprilIn period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in. In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4. In period III (double-blind withdrawal ): At visit 4, part of the patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).
Placebo to Ramipril	Placebo comparator	Drug: Matching placebo to RamiprilIn period III (double-blind withdrawal ): At visit 4, part of patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
Placebo to Aliskiren	Placebo comparator	Drug: Matching placebo to AliskirenIn period III (double-blind withdrawal ): At visit 4, part of the patients from Aliskiren arm received placebo to Aliskiren for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Outpatients > 18 years
Male or female patients. Female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
Patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
BP thresholds at visit 1:
BP thresholds at visit 2 (for all patients):

Key exclusion criteria (9 listed)

Women of child-bearing potential not using any effective methods of contraception
Severe hypertension (office BP ≥ 180/110 mmHg)
Impossibility to stop abruptly previous antihypertensive treatments at visit 1
Patients previously untreated or patients treated with two or three antihypertensive medications
History or evidence of a secondary form of hypertension

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
Aliskiren150 mg Aliskiren as film-coated tablet	Drug	Aliskiren
RamiprilRamipril 5 mg was given in capsule form.	Drug	Ramipril
Matching placebo to AliskirenThe tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm.	Drug	Placebo to Aliskiren, Ramipril
Matching placebo to RamiprilThe placebo capsule to ramipril 5 mg for period I and III. In period II, matching placebo to Ramipril was given to Aliskiren active treatment arm.	Drug	Aliskiren, Placebo to Ramipril

Primary outcome

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline to 8 weeks
The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP as covariable.

8 secondary outcomes

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline to 8 weeks
Percentage of Patients With Controlled Blood Pressure
Time frame: At 4 and 8 weeks
Number of the Participants With More Than 55 mmHg Difference Between the Mean SBP Measured at the Morning Surge and the Mean Minimal SBP Measured During the Night
Time frame: After 8 weeks
Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)
Time frame: Baseline to 4 weeks
Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8
Time frame: At week 8
Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)
Time frame: Baseline to 8 weeks
Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) From Last Active Dose Taken to After a One-day Missed-dose
Time frame: From 8 weeks to 48 hours after week 8
Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)
Time frame: 8 weeks + 1 day

Results and safety

Results posted to the registry on 3 Apr 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
Ramipril	257	247
Placebo to Ramipril	0	0
Aliskiren	249	241
Placebo to Aliskiren	0	0

Primary outcome: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Time frame: Baseline to 8 weeks. Least squares mean (Standard Error). Unit: mmHg

Measure	Ramipril n = 213	Aliskiren n = 213
Value	-18.80 (0.92)	-20.78 (0.92)

Population analysed: Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks of period II + 1 day of Period III. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ramipril (Period II and III)	3 of 257 (1.2%)	0 of 257 (0%)	Not reported
Placebo to Ramipril (Period III)	0 of 118 (0%)	0 of 118 (0%)	Not reported
Aliskiren (Period II and III)	1 of 248 (0.4%)	0 of 248 (0%)	Not reported
Placebo to Aliskiren (Period III)	0 of 122 (0%)	0 of 122 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aliskiren and Ramipril in people with Essential Hypertension, run by Novartis at 98 sites in France.

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 9 inclusion and 9 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 3 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in France. 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 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?

Yes. Results are posted in the registry (first posted 3 Apr 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 Systolic Blood Pressure (msSBP) (time frame: Baseline to 8 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 NCT01042392, 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 3 Apr 2012.