HypertensionPhase 2/3RAVEL-1NCT00284128
AVE7688 in Patients With Mild to Moderate Blood Pressure
A Phase 2/3 study testing AVE7688 and Losartan-potassium in people with Hypertension, run by Sanofi at 21 sites in 21 countries.
Trial summary
The primary objective is to assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough diastolic blood pressure at the end of week 12. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- AVE7688 and Losartan-potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,940 participants
- Where
- 21 sitesin 21 countries
- Study dates
- Dec 2005to Mar 2008
- Phase
- Phase 2/3
- 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
- Patients with mild-to-moderate, treated or untreated, essential hypertension, as defined by the JNC VII (Joint National Committee on the Prevention, Detection, Evaluation, and
- Treatment of High Blood Pressure, Seventh report ) guidelines who meet the following BP eligibility criteria:
- mean SeSBP (Seated systolic blood pressure) ≥140 mm Hg and <180 mm Hg and mean SeDBP (Seated diastolic blood pressure) ≥90 mm Hg and <110 mm Hg at two consecutive qualifying visits in the placebo lead-in phase
- variability between the mean BP measurements on the 2 consecutive qualifying visits is less or equal 7 mm Hg for SeDBP.
Who cannot join
- Refusal or inability to give informed consent
- Patients who have previously been treated with AVE7688
- Patients who cannot stop their anti-hypertensive treatment
- Known history of secondary hypertension, including patients with endocrine disorders such as pheochromocytoma, active hyperthyroidism, or untreated hypothyroidism
- Severe hypertension
- Women of child bearing potential, who have a positive serum pregnancy test, or who do not agree to use an accepted method of contraception
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- Women who are breast feeding
- Patients with non-cardiac progressive fatal disease
- Patients with immunological or hematological disorders
- Requirement for concomitant treatment that could bias the primary evaluation
- Unstable insulin-dependent diabetes mellitus
- History of stroke, intracranial hemorrhage or transitory ischemic attack within the previous year
- Likelihood of poor compliance both with treatment and study design
- Patient is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, or other staff member or relative there of directly involved in the conduct of the study
- Administration of any investigational drug within the preceding 30 days
- Abuse of drugs or alcoholic beverages within 1 year prior to the start of the study
- Patients taking herbal or dietary compounds that have the potential to influence blood pressure
- Contraindications to losartan-potassium as per local package insert
- History of hypersensitivity or angioedema with ACE inhibitors or NEP inhibitors, patients with hereditary or idiopathic angioedema, patients with allergic reaction in which urticaria or angioedema was the manifestation
- Impaired hepatic function
- Known unilateral or bilateral renal artery stenosis
- Serum potassium > 5.5 mmol/L
- Impaired renal function
Trial locations and contacts
21 sites in 21 countries.
21 sites in 21 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: Double-blind, Randomized, Parallel-group, Dose Ranging, Multicenter Study to Evaluate the Efficacy and Safety of 2.5, 10, 35 and 50 mg AVE 7688 Once Daily, Using 100 mg Losartan-potassium Once Daily as Calibrator, for 12 Months Treatment, in Patients With Mild to Moderate Hypertension
The primary objective is to assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough diastolic blood pressure at the end of week 12.
The secondary objectives are:
- To assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough systolic blood pressure at the end of week 12
- To compare the percentages of responders after 12 week of treatment
- To evaluate the long term safety and tolerability of AVE 7688 with particular attention to angioedema
Read the detailed description
This study is a prospective multi-center, randomized, double-blind, active-controlled parallel-group, dose ranging study with 5 treatment groups (AVE7688 at 4 different dosages, and losartan-potassium 100 mg). There will be 3 study phases: placebo lead-in, treatment, and follow-up.
During the placebo lead-in phase (duration 3 to 4 weeks), patients will discontinue concomitant treatment with any antihypertensive or vasodilating agents and will receive single-blind placebo until randomization. Patients who meet the inclusion and exclusion criteria will be randomized to receive once-daily oral doses of either 2.5, 10, 35 or 50 mg AVE7688, or 100 mg losartan-potassium.
The treatment phase will consist of two parts: an efficacy evaluation period, with a 2 week titration period (from randomization to week 2, visit T1 to visit T3) up to 12 weeks, followed by a long-term safety evaluation period until the end of week 52. Antihypertensive treatment such as diuretics, beta blockers or calcium channel blockers can be introduced or re-introduced if indicated during the long term safety evaluation period but angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARBs) are not permitted.
An additional visit (visit F1) will occur two weeks after the last dose of study medication.
- Conditions
- Hypertension
- Being tested
- AVE7688, Losartan-potassium
- Keywords
- Cardiovascular Disease C14, vascular disease C14.907, hypertension C14.907.489
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVE7688Drug
Also called ilepatril
oral administration (capsules)
Losartan-potassiumDrug
oral administration (capsules)
| Study group | Role | What they receive |
|---|---|---|
| ilepatril (2.5 mg ) once daily | Experimental | AVE7688 oral administration Receives: Drug: AVE7688 |
| ilepatril (10 mg) once daily | Experimental | AVE7688 oral administration Receives: Drug: AVE7688 |
| ilepatril (35 mg) once daily | Experimental | AVE7688 oral administration Receives: Drug: AVE7688 |
| ilepatril (50 mg) once daily | Experimental | AVE7688 oral administration Receives: Drug: AVE7688 |
| Losartan-potassium (100 mg) once daily | Other | oral administration Receives: Drug: Losartan-potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in trough diastolic blood pressure at the end of week 12.
Measured: 12 weeks
Secondary outcomes (2)
Change from baseline in trough systolic blood pressure at the end of week 12, percentages of responders after 12 week of treatment.
Measured: 12 weeks
Evaluation of long term safety and tolerability of AVE7688 with particular attention to angioedema.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,940 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284128
- Sponsor's protocol ID
- DFI6032
- Acronym
- RAVEL-1
- Status last verified
- Apr 2016
- First submitted
- 30 Jan 2006
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Parallel-group, Dose Ranging, Multicenter Study to Evaluate the Efficacy and Safety of 2.5, 10, 35 and 50 mg AVE 7688 Once Daily, Using 100 mg Losartan-potassium Once Daily as Calibrator, for 12 Months Treatment, in Patients With Mild to Moderate Hypertension
- ClinicalTrials.gov ID
- NCT00284128
- Acronym / sponsor ID
- RAVEL-1 / DFI6032
- Conditions
- Hypertension
- Keywords
- Cardiovascular Disease C14, vascular disease C14.907, hypertension C14.907.489
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,940 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 31 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough diastolic blood pressure at the end of week 12.
The secondary objectives are:
- To assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough systolic blood pressure at the end of week 12
- To compare the percentages of responders after 12 week of treatment
- To evaluate the long term safety and tolerability of AVE 7688 with particular attention to angioedema
Detailed description
This study is a prospective multi-center, randomized, double-blind, active-controlled parallel-group, dose ranging study with 5 treatment groups (AVE7688 at 4 different dosages, and losartan-potassium 100 mg). There will be 3 study phases: placebo lead-in, treatment, and follow-up.
During the placebo lead-in phase (duration 3 to 4 weeks), patients will discontinue concomitant treatment with any antihypertensive or vasodilating agents and will receive single-blind placebo until randomization. Patients who meet the inclusion and exclusion criteria will be randomized to receive once-daily oral doses of either 2.5, 10, 35 or 50 mg AVE7688, or 100 mg losartan-potassium.
The treatment phase will consist of two parts: an efficacy evaluation period, with a 2 week titration period (from randomization to week 2, visit T1 to visit T3) up to 12 weeks, followed by a long-term safety evaluation period until the end of week 52. Antihypertensive treatment such as diuretics, beta blockers or calcium channel blockers can be introduced or re-introduced if indicated during the long term safety evaluation period but angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARBs) are not permitted.
An additional visit (visit F1) will occur two weeks after the last dose of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ilepatril (2.5 mg ) once daily | Experimental | Drug: AVE7688AVE7688 oral administration |
| ilepatril (10 mg) once daily | Experimental | Drug: AVE7688AVE7688 oral administration |
| ilepatril (35 mg) once daily | Experimental | Drug: AVE7688AVE7688 oral administration |
| ilepatril (50 mg) once daily | Experimental | Drug: AVE7688AVE7688 oral administration |
| Losartan-potassium (100 mg) once daily | Other | Drug: Losartan-potassiumoral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with mild-to-moderate, treated or untreated, essential hypertension, as defined by the JNC VII (Joint National Committee on the Prevention, Detection, Evaluation, and
- Treatment of High Blood Pressure, Seventh report ) guidelines who meet the following BP eligibility criteria:
- mean SeSBP (Seated systolic blood pressure) ≥140 mm Hg and <180 mm Hg and mean SeDBP (Seated diastolic blood pressure) ≥90 mm Hg and <110 mm Hg at two consecutive qualifying visits in the placebo lead-in phase
- variability between the mean BP measurements on the 2 consecutive qualifying visits is less or equal 7 mm Hg for SeDBP.
Key exclusion criteria (23 listed)
- Refusal or inability to give informed consent
- Patients who have previously been treated with AVE7688
- Patients who cannot stop their anti-hypertensive treatment
- Known history of secondary hypertension, including patients with endocrine disorders such as pheochromocytoma, active hyperthyroidism, or untreated hypothyroidism
- Severe 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 |
|---|---|---|
| AVE7688Also: ilepatriloral administration (capsules) | Drug | ilepatril (10 mg) once daily, ilepatril (2.5 mg ) once daily, ilepatril (35 mg) once daily, ilepatril (50 mg) once daily |
| Losartan-potassiumoral administration (capsules) | Drug | Losartan-potassium (100 mg) once daily |
Primary outcome
Change from baseline in trough diastolic blood pressure at the end of week 12.
Time frame: 12 weeks
2 secondary outcomes
Change from baseline in trough systolic blood pressure at the end of week 12, percentages of responders after 12 week of treatment.
Time frame: 12 weeks
Evaluation of long term safety and tolerability of AVE7688 with particular attention to angioedema.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Individual participant dataSharing planned: No
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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.
Clinical Sciences & Operations study director
Sanofi
21 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AVE7688 and Losartan-potassium in people with Hypertension, run by Sanofi at 21 sites in 21 countries.
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 23 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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Argentina, Brazil, Canada, Chile and 16 more countries. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Change from baseline in trough diastolic blood pressure at the end of week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2016.