A Study in Chinese Mild to Moderate Hypertensive Patients Comparing the Efficacy of Co-Diovan Wit… (NCT00250562) | Clinical Trial Compass
CompletedPhase 3
A Study in Chinese Mild to Moderate Hypertensive Patients Comparing the Efficacy of Co-Diovan With Diovan.
United States1,171 participantsStarted 2005-10
Plain-language summary
Valsartan, an orally active angiotensin II receptor blocker, is registered in most countries worldwide for the treatment of hypertension. In China the usual recommended starting and maintenance dose is 80 mg o.d. The combination of HCTZ 12.5 mg with valsartan 80 mg has been shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected patients6. This fixed combination is registered in most countries worldwide.
The potential benefits of these combinations should be evaluated in patients not adequately controlled by valsartan 80 mg monotherapy. This study will compare the efficacy, safety and tolerability of adding HCTZ 12.5 mg to valsartan 80 mg in those hypertensive patients.
This study is not recruiting in the US.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Male or female Outpatients 18 years and older.
* Patients with hypertension defined as the following:
* Newly diagnosed hypertensive patients should have a MSDBP \> 95 mmHg and \< 110 mmHg.at Visit 1 and 2, Pre-treated hypertensive patients should have a MSDBP \> 95 mmHg and \< 110 mmHg at Visit 2
* For entrance into the double-blind treatment period (Visit 3), all patients should have a MSDBP of \> 90 mmHg and \< 110 mmHg
* Patients must have given written informed consent to participate and be willing to participate in the entire study
Exclusion Criteria:
\-
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline diastolic blood pressure after 8 weeks