HypertensionPhase 4ASTRIDENCT00787605
Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus
A Phase 4 study testing Amlodipine, Hydrochlorothiazide (HCTZ) and Aliskiren in people with Hypertension and Diabetes Mellitus, run by Novartis at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and < 200 mm Hg). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus
- What is being tested?
- Amlodipine, Hydrochlorothiazide (HCTZ) and Aliskiren
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2010
- 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
- Male or female outpatients ≥ 18 years old.
- Patients with a diagnosis of stage 2 hypertension (defined as an office cuff msSBP ≥ 160 mmHg and < 200 mmHg) at Visit 5 (randomization).
- Patients with diabetes mellitus (Type 2) with an HbA1c at visit 1 ≤ 9.0 % and currently on stable anti-diabetic regimen or stable diet and exercise for at least 4 weeks prior to visit 1.
- Patients who are eligible and able to participate in the study, and who are willing to give written informed consent before any assessment is performed.
Who cannot join
- Office blood pressure measured by cuff (msSBP ≥ 200 mmHg or msDBP ≥ 110 mmHg) at Visits 1-5.
- History or evidence of secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma).
- History of hypertensive encephalopathy or heart failure (NYHA Class II-IV).
- Cerebrovascular accident, transient ischemic cerebral attack (TIA), coronary bypass surgery, myocardial infarction or any percutaneous coronary intervention (PCI) within 1 year prior to Visit 1.
- Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L (corresponding to 3.5 mmol/L) or ≥ 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit 1.
- Pregnant or nursing (lactating) women, where 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).
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- Use of other investigational drugs within 30 days of enrollment.
- History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (thiazide diuretics, renin inhibitors, calcium channel blockers, or dihydropyridine like calcium channel blockers) as the study drugs.
- History of gouty arthritis.
- Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
- Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
- Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL (and estradiol< 20 pg/mL) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- Current angina pectoris requiring pharmacological therapy (except sublingual nitroglycerin).
- Second or third degree heart block without a pacemaker.
- Atrial fibrillation or atrial flutter at Visit 1, or potentially life-threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1.
- Clinically significant valvular heart disease.
- History of angioedema during use of an ACE inhibitor.
- History or evidence of drug or alcohol abuse within the last 12 months.
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
- History of active inflammatory bowel disease during the 12 months prior to Visit 1.
- Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal bleeding during the 3 months prior to Visit 1.
- Any history of pancreatic injury, pancreatitis, or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase during the 12 months prior to Visit 1.
- Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
- Evidence of renal impairment as determined by any one of the following: serum creatinine > 1.5 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
- Current treatment with cholestyramine or colestipol resins
- History of noncompliance to medical regimes or unwillingness to comply with the study protocol.
- Any condition that in the opinion of the investigator would confound the evaluation and interpretation of efficacy and/or safety data.
- Persons directly involved in the execution of this protocol.
- Known contraindications to the study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An 8-week Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to Amlodipine (10 mg) in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and < 200 mm Hg).
- Conditions
- Hypertension, Diabetes Mellitus
- Being tested
- Amlodipine, Hydrochlorothiazide (HCTZ), Aliskiren
- Keywords
- Hypertension, diabetes mellitus, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, amlodipine, stage 2
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks
Hydrochlorothiazide (HCTZ)Drug
Hydrochlorothiazide 12.5 mg for 1 week followed by Hydrochlorothiazide 25 mg for 7 weeks
AliskirenDrug
Aliskiren 150 mg for 1 week followed by Aliskiren 300 mg for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine | Active comparator | Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks Receives: Drug: Amlodipine |
| Aliskiren / HCTZ | Experimental | Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks Receives: Drug: Hydrochlorothiazide (HCTZ); Drug: 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)
Measured: Baseline and Week 8
Secondary outcomes (5)
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Measured: Baseline and Week 8
Percentage of Responders
Response defined by mean sitting Systolic Blood Pressure < 130 mm Hg or a reduction of mean sitting Systolic Blood Pressure >= 20 mm Hg from baseline
Measured: Week 8
Percentage of Patients Achieving Blood Pressure Control
Blood pressure control is defined as patient achieving a target Blood Pressure of mean sitting Systolic BloodPressure / mean sitting Diastolic Blood Pressure < 130/80 mmHg.
Measured: after 8 weeks of treatment
Biomarker Measurements
Geometric mean of the post to baseline ratio in biomarkers of plasma renin activity (ng/ml/h), plasma renin concentration (ng/L), and cystatin C (mg/L)
Measured: Baseline and Week 8
Evaluate the Safety and Tolerability
Percentage of patients with Adverse Event and percentage of patients with edema
Measured: after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2010
- Study completionJan 2010
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787605
- Sponsor's protocol ID
- CSPP100A2409
- Acronym
- ASTRIDE
- Status last verified
- May 2011
- First submitted
- 5 Nov 2008
- Last updated
- 27 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to Amlodipine (10 mg) in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00787605
- Acronym / sponsor ID
- ASTRIDE / CSPP100A2409
- Conditions
- Hypertension, Diabetes Mellitus
- Keywords
- Hypertension, diabetes mellitus, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, amlodipine, stage 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Posted 23 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and < 200 mm Hg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlodipine | Active comparator | Drug: AmlodipineAmlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks |
| Aliskiren / HCTZ | Experimental | Drug: Hydrochlorothiazide (HCTZ), Drug: AliskirenAliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female outpatients ≥ 18 years old.
- Patients with a diagnosis of stage 2 hypertension (defined as an office cuff msSBP ≥ 160 mmHg and < 200 mmHg) at Visit 5 (randomization).
- Patients with diabetes mellitus (Type 2) with an HbA1c at visit 1 ≤ 9.0 % and currently on stable anti-diabetic regimen or stable diet and exercise for at least 4 weeks prior to visit 1.
- Patients who are eligible and able to participate in the study, and who are willing to give written informed consent before any assessment is performed.
Key exclusion criteria (34 listed)
- Office blood pressure measured by cuff (msSBP ≥ 200 mmHg or msDBP ≥ 110 mmHg) at Visits 1-5.
- History or evidence of secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma).
- History of hypertensive encephalopathy or heart failure (NYHA Class II-IV).
- Cerebrovascular accident, transient ischemic cerebral attack (TIA), coronary bypass surgery, myocardial infarction or any percutaneous coronary intervention (PCI) within 1 year prior to Visit 1.
- Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L (corresponding to 3.5 mmol/L) or ≥ 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit 1.
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 |
|---|---|---|
| AmlodipineAmlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks | Drug | Amlodipine |
| Hydrochlorothiazide (HCTZ)Hydrochlorothiazide 12.5 mg for 1 week followed by Hydrochlorothiazide 25 mg for 7 weeks | Drug | Aliskiren / HCTZ |
| AliskirenAliskiren 150 mg for 1 week followed by Aliskiren 300 mg for 7 weeks | Drug | Aliskiren / HCTZ |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline and Week 8
5 secondary outcomes
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline and Week 8
Percentage of Responders
Time frame: Week 8
Percentage of Patients Achieving Blood Pressure Control
Time frame: after 8 weeks of treatment
Biomarker Measurements
Time frame: Baseline and Week 8
Evaluate the Safety and Tolerability
Time frame: after 8 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- 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 study chair
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine, Hydrochlorothiazide (HCTZ) and Aliskiren in people with Hypertension and Diabetes Mellitus, run by Novartis 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 34 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 27 Oct 2016. 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 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 23 May 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 (msSBP) (time frame: Baseline and Week 8). 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 27 Oct 2016.