HypertensionPhase 4NCT01172431
Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency
A Phase 4 study testing Indapamide and Hydrochlorothiazide in people with Hypertension and Renal Insufficiency, run by West China Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal function, endothelial function, blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Hypertension, Renal Insufficiency
- What is being tested?
- Indapamide and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Dec 2013
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Creatinine clearance 30 to 90 mL/min/1.73 m2, with variations of less than 20 percent in the 2 weeks before the screening evaluation.
- Diagnosed hypertension according to guidelines or having taken anti-hypertension drugs.
- Aged between 65 and 85 years.
- Willingness to provide written, informed consent.
- Ability to adhere to study protocol.
Who cannot join
- Secondary hypertension.
- Diabetes mellitus.
- Atrial flutter/atrial fibrillation.
- Symptoms of congestive heart failure (NYHA III-IV) or there is evidence that left ventricular EF < 40%.
- Recent (< 6 months) myocardial infarction or cerebrovascular ischemic symptoms.
- Recent (< 3 months) or planned coronary revascularization: PCI (percutaneous coronary intervention)/CABG (coronary artery by-pass graft).
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- Severe valvular heart disease.
- History of hypersensitivity to indapamide, thiazides or to any of the components of the products.
- Any current condition or other disease known to interfere significantly with the absorption, distribution, metabolism or excretion of study drugs.
- Participation to another investigational study in the last 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: A Comparison of Indapamide SR 1.5 mg With Hydrochlorothiazide 25 mg, in Combination With an ACE-inhibitor, in Old Patients With Mild to Moderate Renal Insufficiency and Hypertension
The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal function, endothelial function, blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.
- Conditions
- Hypertension, Renal Insufficiency
- Being tested
- Indapamide, Hydrochlorothiazide
- Keywords
- hypertension, renal insufficiency, indapamide, hydrochlorothiazide
- Medical subject headings
- Hypertension, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndapamideDrug
Indapamide SR 1.5mg qd
HydrochlorothiazideDrug
Hydrochlorothiazide 25mg qd
| Study group | Role | What they receive |
|---|---|---|
| Indapamide | Experimental | Indapamide SR 1.5mg qd Receives: Drug: Indapamide |
| Hydrochlorothiazide | Active comparator | Hydrochlorothiazide 25mg qd Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function
Effects of indapamide SR 1.5 mg on renal function by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.
Measured: 1 year
Secondary outcomes (2)
endothelial function
Effects of indapamide SR 1.5 mg on endothelial function by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.
Measured: 1 year
blood pressure variability
Effects of indapamide SR 1.5 mg on blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionDec 2013
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 West China HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Chen, West China Hospital
- Investigators
- Xiao P Chen, master, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172431
- Sponsor's protocol ID
- WestChinaH
- Status last verified
- Jun 2014
- First submitted
- 26 Jul 2010
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Indapamide SR 1.5 mg With Hydrochlorothiazide 25 mg, in Combination With an ACE-inhibitor, in Old Patients With Mild to Moderate Renal Insufficiency and Hypertension
- ClinicalTrials.gov ID
- NCT01172431
- Acronym / sponsor ID
- WestChinaH
- Conditions
- Hypertension, Renal Insufficiency
- Keywords
- hypertension, renal insufficiency, indapamide, hydrochlorothiazide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jul 2010 (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 purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal function, endothelial function, blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indapamide | Experimental | Drug: IndapamideIndapamide SR 1.5mg qd |
| Hydrochlorothiazide | Active comparator | Drug: HydrochlorothiazideHydrochlorothiazide 25mg qd |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Creatinine clearance 30 to 90 mL/min/1.73 m2, with variations of less than 20 percent in the 2 weeks before the screening evaluation.
- Diagnosed hypertension according to guidelines or having taken anti-hypertension drugs.
- Aged between 65 and 85 years.
- Willingness to provide written, informed consent.
- Ability to adhere to study protocol.
Key exclusion criteria (10 listed)
- Secondary hypertension.
- Diabetes mellitus.
- Atrial flutter/atrial fibrillation.
- Symptoms of congestive heart failure (NYHA III-IV) or there is evidence that left ventricular EF < 40%.
- Recent (< 6 months) myocardial infarction or cerebrovascular ischemic symptoms.
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 |
|---|---|---|
| IndapamideIndapamide SR 1.5mg qd | Drug | Indapamide |
| HydrochlorothiazideHydrochlorothiazide 25mg qd | Drug | Hydrochlorothiazide |
Primary outcome
renal function
Time frame: 1 year
Effects of indapamide SR 1.5 mg on renal function by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.
2 secondary outcomes
endothelial function
Time frame: 1 year
blood pressure variability
Time frame: 1 year
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 24 Jun 2014.
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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.
Xiao P Chen, master principal investigator
West China Hospital
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 Indapamide and Hydrochlorothiazide in people with Hypertension and Renal Insufficiency, run by West China Hospital at 1 site in China.
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 5 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 24 Jun 2014. 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 China. 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?
renal function (time frame: 1 year). 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 24 Jun 2014.